Allergen-Specific IgE Assay 12 Allergen Bundle
Summary
Hitachi Chemical Diagnostics, Inc. received 510(k) clearance for Allergen-Specific IgE Assay 12 Allergen Bundle, a DHB device. Cleared on 2021-10-18.
Details
Source
510(k) Clearance
External ID
K193613
Action Date
2021-10-18
Status
Traditional
Category
device
Product Code
DHB
Product Description
Allergen-Specific IgE Assay 12 Allergen Bundle. Product code: DHB.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Hitachi Chemical Diagnostics, Inc. have FDA actions?
This is the only FDA action we have on record for Hitachi Chemical Diagnostics, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K193613" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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