Atlas FDA

CKB

24 FDA 510(k) clearances · Product code

50 daysmedian time to decision
159 days90th percentile
24clearances measured

FDA profile

Official device name
Acid Phosphatase, Naphthyl Phosphate
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1020
Medical specialty
Clinical Chemistry
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RecordFirmDate
DRI-STAT ACID PHOSPHATASE REAGENT (K053612)Beckman Coulter, Inc.2006-04-26
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 (K023840)Bayer Diagnostics Corp.2003-01-07
ACP (K991010)Abbott Diagnostics Mfg., Inc.1999-05-19
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER (K981743)Olympus America, Inc.1998-06-09
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) (K974695)Roche Diagnostic Systems, Inc.1998-05-21
OLYMPUS ACID PHOSPHATASE REAGENT (K963640)Olympus America, Inc.1997-02-18
IL TEST ACID PHOSPHATASE (K943366)Instrumentation Laboratory CO1996-01-29
ACID PHOSPHOTASE REAGENT TEST AND KIT (K902543)Crestat Diagnostics, Inc.1990-09-07
ACID PHOSPHATASE REAGENT SET (K902495)Tech Intl. Co.1990-07-16
ACID PHOSPHATASE REAGENT (K892393)Medical Analysis Systems, Inc.1989-07-20
TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) (K884747)Technicon Instruments Corp.1989-01-30
ACP KINETIC TEST (ACID PHOSPHATASE TEST) (K881204)Sclavo, Inc.1988-04-28
ACID PHOSPHATASE REAGENT (K880798)Trace America, Inc.1988-04-18
ACID PHOSPHATASE (KINETIC) CAT. # 320-06 (K875209)Diagnostic Chemicals, Ltd. (Usa)1988-02-01
ACID PHOSPHATASE (ACP) REAGENT (K863851)Sigma Diagnostics, Inc.1986-10-16
ACID PHOSPHATASE PROCEDURE (K861675)Data Medical Associates, Inc.1986-05-29
VES-TEC/VES-MATIC (K854223)Marvic Interpharma, Inc.1986-04-04
DEMAND ACID PHOSPHATASE REAGENT (K853949)Cooper Biomedical, Inc.1985-10-16
DATA ZYME ACID PHOSPHATASE PROCEDURE (K850902)Data Medical Associates, Inc.1985-03-20
PARAMAX ACID PHOSPHATASE REAGENT (K840661)American Dade1984-04-04
RAICHEM ACID PHASPHATASE REAGENT (K831834)Reagents Applications, Inc.1983-08-26
BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA (K823087)Boehringer Mannheim Corp.1982-11-18
SPINCHEM ACID PHOSPHATASE REAGENT (K821674)Smithkline Diagnostics, Inc.1982-06-22
GILCHEM ACID PHOSPHATASE REAGENT (K820975)Gilford Diagnostics1982-04-26

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Every clearance here is in the API, with alerts when new ones post.