510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K892393Substantially Equivalent

Acid Phosphatase Reagent

Medical Analysis Systems, Inc., Camarillo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892393 is the FDA 510(k) clearance record for ACID PHOSPHATASE REAGENT, a class II device, cleared for Medical Analysis Systems, Inc. on under FDA product code CKB (Acid Phosphatase, Naphthyl Phosphate). FDA records list 107 510(k) clearances for Medical Analysis Systems, Inc., from to . As of , FDA records show no recalls naming K892393.

Clearance record

Decision date
Received
(104 days to decision)
Product code
CKB Acid Phosphatase, Naphthyl Phosphate
Regulation
21 CFR 862.1020
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Medical Analysis Systems, Inc. Lincoln Technology Park, Camarillo CA
Third party review
No

Clearances, product code CKB

Trailing 12 months

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

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