510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821660Substantially Equivalent

Bio-Check Gram Stain Control

American Scientific Products, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821660 is the FDA 510(k) clearance record for BIO-CHECK GRAM STAIN CONTROL, a class I device, cleared for American Scientific Products on under FDA product code JTR (Kit, Quality Control For Culture Media). FDA records list 28 510(k) clearances for American Scientific Products, from to . As of , FDA records show no recalls naming K821660.

Clearance record

Decision date
Received
(21 days to decision)
Product code
JTR Kit, Quality Control For Culture Media
Regulation
21 CFR 866.2480
Device class
Class I
Review panel
Microbiology
Applicant
American Scientific Products 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JTR

Trailing 12 months

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

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