510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800239Substantially Equivalent

Rh-Hr Negative Control Reagent

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

K800239 is the FDA 510(k) clearance record for RH-HR NEGATIVE CONTROL REAGENT, a class II device, cleared for Gotham Biologics, Inc. on under FDA product code KSF (Kit, Quality Control For Blood Banking Reagents). FDA records list 2 510(k) clearances for Gotham Biologics, Inc., from to . As of , FDA records show no recalls naming K800239.

Clearance record

Decision date
Received
(16 days to decision)
Product code
KSF Kit, Quality Control For Blood Banking Reagents
Regulation
21 CFR 864.9650
Device class
Class II
Review panel
Hematology
Applicant
Gotham Biologics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KSF

Trailing 12 months

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

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