FDA Product Code CIN: Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Leading manufacturers include Helena Laboratories, Sigma Chemical Co. and Immunodiagnostic Systems , Ltd..
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
Cleared
Apr 15, 2024
Access Ostase
Beckman Coulter
Chemistry
210d
Cleared
Sep 30, 2020
IDS-iSYS Ostase BAP
Immunodiagnostic Systems , Ltd.
Chemistry
217d
Cleared
May 06, 2002
SPIFE 2000/3000 ALP 40, 20
Helena Laboratories
Chemistry
69d
Cleared
Mar 28, 2000
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
Beckman Coulter, Inc.
Chemistry
99d
Cleared
Sep 23, 1992
TITAN GEL ALKALINE PHOSPHATASE (HR)
Helena Laboratories
Chemistry
174d
Cleared
Jul 30, 1991
REP ALP-15, 8, & 4 KITS
Helena Laboratories
Chemistry
50d
Cleared
Mar 08, 1989
ALKALINE PHOSPHATASE ISOENZYME REAGENTS
Beckman Instruments, Inc.
Chemistry
49d
Cleared
Feb 23, 1989
TITAN GEL ALKALINE PHOSPHATASE (HR)
Helena Laboratories
Chemistry
57d
Cleared
Jun 01, 1987
ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT
Helena Laboratories
Chemistry
88d
Cleared
Aug 03, 1977
AP ISOTROL, #A 0140
Sigma Chemical Co.
Chemistry
29d
Cleared
Nov 02, 1976
PROCEDURE NO. 710-EP FOR ALK.PHOS.
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.