510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K822810Substantially Equivalent

Phadebact Csf Test 20

Pharmacia, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822810 is the FDA 510(k) clearance record for PHADEBACT CSF TEST 20, a class II device, cleared for Pharmacia, Inc. on under FDA product code GTJ (Antisera, All Groups, N. Meningitidis). FDA records list 129 510(k) clearances for Pharmacia, Inc., from to . As of , FDA records show no recalls naming K822810.

Clearance record

Decision date
Received
(101 days to decision)
Product code
GTJ Antisera, All Groups, N. Meningitidis
Regulation
21 CFR 866.3390
Device class
Class II
Review panel
Microbiology
Applicant
Pharmacia, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GTJ

Trailing 12 months

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

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