510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963954Substantially Equivalent

Cd 19 R-Pe, Cd19 Tri-Color Monoclonal Antibody

Caltag Laboratories, Inc., Dowingtown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963954 is the FDA 510(k) clearance record for CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY, a class II device, cleared for Caltag Laboratories, Inc. on under FDA product code GKZ (Counter, Differential Cell). FDA records list 12 510(k) clearances for Caltag Laboratories, Inc., from to . As of , FDA records show no recalls naming K963954.

Clearance record

Decision date
Received
(54 days to decision)
Product code
GKZ Counter, Differential Cell
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Caltag Laboratories, Inc. 605 Dilworth Rd., Dowingtown PA
510(k) summary
Summary
Third party review
No

Clearances, product code GKZ

Trailing 12 months
4 clearances under product code GKZ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GKZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260