510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821963Substantially Equivalent

Eia-F8 Enzymeimmunoassay Kit for Quant.

Intl. Immunoassay Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821963 is the FDA 510(k) clearance record for EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT., a class II device, cleared for Intl. Immunoassay Laboratories, Inc. on under FDA product code GGP (Test, Qualitative And Quantitative Factor Deficiency). FDA records list 27 510(k) clearances for Intl. Immunoassay Laboratories, Inc., from to . As of , FDA records show no recalls naming K821963.

Clearance record

Decision date
Received
(26 days to decision)
Product code
GGP Test, Qualitative And Quantitative Factor Deficiency
Regulation
21 CFR 864.7290
Device class
Class II
Review panel
Hematology
Applicant
Intl. Immunoassay Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GGP

Trailing 12 months

FDA records hold no clearances under product code GGP in the trailing twelve months.

FDA records show no clearances under product code GGP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GGP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260