510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791282Substantially Equivalent

Anti-Human Serum

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

K791282 is the FDA 510(k) clearance record for ANTI-HUMAN SERUM, a class I device, cleared for Diagnostica, Inc. on under FDA product code DGQ (Whole Blood Plasma, Antigen, Antiserum, Control). FDA records list 12 510(k) clearances for Diagnostica, Inc., from to . As of , FDA records show no recalls naming K791282.

Clearance record

Decision date
Received
(99 days to decision)
Product code
DGQ Whole Blood Plasma, Antigen, Antiserum, Control
Regulation
21 CFR 866.5700
Device class
Class I
Review panel
Immunology
Applicant
Diagnostica, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DGQ

Trailing 12 months

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

FDA records show no clearances under product code DGQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DGQ, 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