510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K946387Substantially Equivalent

Capra (Caprac-R) Wipetest and Well Counter

Mirion Technologies (Capintec), Inc., Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946387 is the FDA 510(k) clearance record for CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER, a class I device, cleared for Capintec, Inc. on under FDA product code JJJ (Counter (Beta, Gamma) For Clinical Use). FDA records list 15 510(k) clearances for MIRION TECHNOLOGIES (CAPINTEC), INC, from to . As of , FDA records show no recalls naming K946387.

Clearance record

Decision date
Received
(125 days to decision)
Product code
JJJ Counter (Beta, Gamma) For Clinical Use
Regulation
21 CFR 862.2320
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Capintec, Inc. 540 Alpha Dr., Pittsburgh PA
510(k) summary
Statement
Third party review
No

Clearances, product code JJJ

Trailing 12 months

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

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