CKB · Class II · 21 CFR 862.1020

FDA Product Code CKB: Acid Phosphatase, Naphthyl Phosphate

Leading manufacturers include Data Medical Associates, Inc., Olympus America, Inc. and Beckman Coulter, Inc..

24
Total
24
Cleared
84d
Avg days
1982
Since

FDA 510(k) Cleared Acid Phosphatase, Naphthyl Phosphate Devices (Product Code CKB)

24 devices
1–24 of 24
Cleared Apr 26, 2006
DRI-STAT ACID PHOSPHATASE REAGENT
K053612
Beckman Coulter, Inc.
Chemistry · 120d
Cleared Jun 09, 1998
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
K981743
Olympus America, Inc.
Chemistry · 22d
Cleared May 21, 1998
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)
K974695
Roche Diagnostic Systems, Inc.
Chemistry · 156d
Cleared Feb 18, 1997
OLYMPUS ACID PHOSPHATASE REAGENT
K963640
Olympus America, Inc.
Chemistry · 159d
Cleared Jan 29, 1996
IL TEST ACID PHOSPHATASE
K943366
Instrumentation Laboratory CO
Chemistry · 565d
Cleared Jul 20, 1989
ACID PHOSPHATASE REAGENT
K892393
Medical Analysis Systems, Inc.
Chemistry · 104d
Cleared Jan 30, 1989
TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)
K884747
Technicon Instruments Corp.
Chemistry · 77d
Cleared Apr 28, 1988
ACP KINETIC TEST (ACID PHOSPHATASE TEST)
K881204
Sclavo, Inc.
Chemistry · 38d
Cleared Feb 01, 1988
ACID PHOSPHATASE (KINETIC) CAT. # 320-06
K875209
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 45d
Cleared Oct 16, 1986
ACID PHOSPHATASE (ACP) REAGENT
K863851
Sigma Diagnostics, Inc.
Chemistry · 14d
Cleared May 29, 1986
ACID PHOSPHATASE PROCEDURE
K861675
Data Medical Associates, Inc.
Chemistry · 29d
Cleared Mar 20, 1985
DATA ZYME ACID PHOSPHATASE PROCEDURE
K850902
Data Medical Associates, Inc.
Chemistry · 15d
Cleared Apr 04, 1984
PARAMAX ACID PHOSPHATASE REAGENT
K840661
American Dade
Hematology · 49d
Cleared Aug 26, 1983
RAICHEM ACID PHASPHATASE REAGENT
K831834
Reagents Applications, Inc.
Chemistry · 80d
Cleared Nov 18, 1982
BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA
K823087
Boehringer Mannheim Corp.
Chemistry · 30d
Cleared Jun 22, 1982
SPINCHEM ACID PHOSPHATASE REAGENT
K821674
Smithkline Diagnostics, Inc.
Hematology · 15d
Cleared Apr 26, 1982
GILCHEM ACID PHOSPHATASE REAGENT
K820975
Gilford Diagnostics
Chemistry · 20d

About Product Code CKB - Regulatory Context