510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K802962Substantially Equivalent

Chem-Assay Standard-Controls

National Bio-Technical Laboratories, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802962 is the FDA 510(k) clearance record for CHEM-ASSAY STANDARD-CONTROLS, a class I device, cleared for National Bio-Technical Laboratories on under FDA product code JJY (Multi-Analyte Controls, All Kinds (Assayed)). FDA records list one 510(k) clearance for National Bio-Technical Laboratories. As of , FDA records show no recalls naming K802962.

Clearance record

Decision date
Received
(31 days to decision)
Product code
JJY Multi-Analyte Controls, All Kinds (Assayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
National Bio-Technical Laboratories 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JJY

Trailing 12 months

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

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