510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800189Substantially Equivalent

Bovine Albumin 22% & 30% Solutions

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

K800189 is the FDA 510(k) clearance record for BOVINE ALBUMIN 22% & 30% SOLUTIONS, a class II device, cleared for Gotham Biologics, Inc. on under FDA product code KSG (Media, Potentiating For In Vitro Diagnostic Use). FDA records list 2 510(k) clearances for Gotham Biologics, Inc., from to . As of , FDA records show no recalls naming K800189.

Clearance record

Decision date
Received
(15 days to decision)
Product code
KSG Media, Potentiating For In Vitro Diagnostic Use
Regulation
21 CFR 864.9600
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 KSG

Trailing 12 months

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

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