CIN · Class II · 21 CFR 862.1050

FDA Product Code CIN: Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

Leading manufacturers include Helena Laboratories, Hybritech, Inc. and Sigma Chemical Co..

26
Total
26
Cleared
95d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Electrophoretic Separation, Alkaline Phosphatase Isoenzymes Devices (Product Code CIN)

26 devices
1–24 of 26
Cleared Apr 15, 2024
Access Ostase
K232904
Beckman Coulter
Chemistry · 210d
Cleared Sep 30, 2020
IDS-iSYS Ostase BAP
K200475
Immunodiagnostic Systems , Ltd.
Chemistry · 217d
Cleared May 06, 2002
SPIFE 2000/3000 ALP 40, 20
K020625
Helena Laboratories
Chemistry · 69d
Cleared Jun 13, 2001
HYDRAGEL ISO-PAL K20 (PN 3022)
K011113
Sebia
Chemistry · 63d
Cleared Mar 28, 2000
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
K994278
Beckman Coulter, Inc.
Chemistry · 99d
Cleared Sep 11, 1997
TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
K972666
Hybritech, Inc.
Chemistry · 57d
Cleared Jan 24, 1997
OPUS BONE ALP
K964764
Behring Diagnostics, Inc.
Chemistry · 58d
Cleared Aug 19, 1996
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K961573
Hybritech, Inc.
Chemistry · 118d
Cleared Apr 26, 1994
RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT
K934013
Isolab, Inc.
Chemistry · 251d
Cleared Jan 11, 1994
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K930810
Hybritech, Inc.
Chemistry · 328d
Cleared Sep 23, 1992
TITAN GEL ALKALINE PHOSPHATASE (HR)
K921578
Helena Laboratories
Chemistry · 174d
Cleared Jul 30, 1991
REP ALP-15, 8, & 4 KITS
K912603
Helena Laboratories
Chemistry · 50d
Cleared Mar 08, 1989
ALKALINE PHOSPHATASE ISOENZYME REAGENTS
K890269
Beckman Instruments, Inc.
Chemistry · 49d
Cleared Feb 23, 1989
TITAN GEL ALKALINE PHOSPHATASE (HR)
K885341
Helena Laboratories
Chemistry · 57d
Cleared Feb 17, 1989
ALKALINE PHOSPHATASE ISOENZYME SYSTEM
K885024
Ciba Corning Diagnostics Corp.
Chemistry · 74d
Cleared Jun 01, 1987
ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT
K870890
Helena Laboratories
Chemistry · 88d
Cleared Feb 25, 1983
ALKALINE PHOSPHATES ISOENZYME SUBSTRATE
K830118
Corning Medical & Scientific
Chemistry · 45d
Cleared Aug 03, 1977
AP ISOTROL, #A 0140
K771225
Sigma Chemical Co.
Chemistry · 29d
Cleared Nov 02, 1976
PROCEDURE NO. 710-EP FOR ALK.PHOS.
K760862
Sigma Chemical Co.
Chemistry · 15d

About Product Code CIN - Regulatory Context

510(k) Submission Activity

26 total 510(k) submissions under product code CIN since 1976, with 26 receiving FDA clearance (average review time: 95 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.