FDA 510(k)

AP ISOTROL, #A 0140

K-Number: K771225 · 1977-08-03

Decision Date1977-08-03

Product CodeCIN

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AP ISOTROL, #A 0140 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1977-08-03 under 510(k) number K771225. The device is classified under product code CIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AP ISOTROL, #A 0140?

AP ISOTROL, #A 0140 is a medical device that received FDA 510(k) clearance on 1977-08-03. The listed applicant is Sigma Chemical Co.. The 510(k) number is K771225.

When did AP ISOTROL, #A 0140 receive FDA 510(k) clearance?

AP ISOTROL, #A 0140 received FDA 510(k) clearance on 1977-08-03, under 510(k) number K771225.

Who is the listed applicant for AP ISOTROL, #A 0140?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AP ISOTROL, #A 0140?

The FDA product code for AP ISOTROL, #A 0140 is CIN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sigma Chemical Co. as applicant

K933694SIGMA GLUCOSE REAGENT K933678SIGMA CALCIUM REAGENT K933696SIGMA ELECTROLYTE REFERENCE REAGENT K933691SIGMA CO2 ALKALINE BUFFER REAGENT K933679SIGMA BUN REAGENT K933703SIGMA WASH CONCENTRATE SOLUTION

View all 231 devices →

Related Devices (Code: CIN)

K232904Access OstaseBeckman Coulter K200475IDS-iSYS Ostase BAPImmunodiagnostic Systems , Ltd.K043125ORION DIAGNOSTICA UNIQ PINP RIAOrion Diagnostica, OY K020625SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346Helena Laboratories K011113HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)Sebia K994278ACCESS OSTASE IMMUNOENZYMETRIC ASSAYBeckman Coulter, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.