Atlas FDA

CIN

26 FDA 510(k) clearances · Product code

63 daysmedian time to decision
217 days90th percentile
26clearances measured

FDA profile

Official device name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1050
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
1993: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Access Ostase (K232904)Beckman Coulter2024-04-15
IDS-iSYS Ostase BAP (K200475)Immunodiagnostic Systems , Ltd.2020-09-30
ORION DIAGNOSTICA UNIQ PINP RIA (K043125)Orion Diagnostica, OY2005-05-04
SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 (K020625)Helena Laboratories2002-05-06
HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) (K011113)Sebia2001-06-13
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY (K994278)Beckman Coulter, Inc.2000-03-28
ALKPHASE-B ASSAY KIT (K981373)Metra Biosystems, Inc.1998-05-27
TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY (K972666)Hybritech, Inc.1997-09-11
OPUS BONE ALP (K964764)Behring Diagnostics, Inc.1997-01-24
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K961573)Hybritech, Inc.1996-08-19
ALKPHASE-B ASSAY KIT (K952768)Metra Biosystems, Inc.1995-08-24
RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (K934013)Isolab, Inc.1994-04-26
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K930810)Hybritech, Inc.1994-01-11
TITAN GEL ALKALINE PHOSPHATASE (HR) (K921578)Helena Laboratories1992-09-23
REP ALP-15, 8, & 4 KITS (K912603)Helena Laboratories1991-07-30
ALKALINE PHOSPHATASE ISOENZYME REAGENTS (K890269)Beckman Instruments, Inc.1989-03-08
TITAN GEL ALKALINE PHOSPHATASE (HR) (K885341)Helena Laboratories1989-02-23
ALKALINE PHOSPHATASE ISOENZYME SYSTEM (K885024)Ciba Corning Diagnostics Corp.1989-02-17
ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT (K870890)Helena Laboratories1987-06-01
ALKALINE PHOSPHATES ISOENZYME SUBSTRATE (K830118)Corning Medical & Scientific1983-02-25
ALKPHOR SYSTEM (K823445)California Immuno Diagnostic, Inc.1982-12-28
ALK-PHOS BIOPAK GEL (K810144)Bioware Products1981-02-02
ALKALINE PHOSPHATASE MARKER (K792548)Electrophoresis Corp. of America1980-01-29
ALKALINE PHOSPHATASE ISOENZY. SUB. SET (K771620)Pfizer, Inc.1977-09-15
AP ISOTROL, #A 0140 (K771225)Sigma Chemical Co.1977-08-03
PROCEDURE NO. 710-EP FOR ALK.PHOS. (K760862)Sigma Chemical Co.1976-11-02

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