Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ALKALINE PHOSPHATASE ISOYZME REAGENT SET

K-Number: K770155 · 1977-01-31

ApplicantGelman Instrument Co.
Decision Date1977-01-31
Product CodeCJO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE ISOYZME REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Gelman Instrument Co.. It received FDA 510(k) clearance on 1977-01-31 under 510(k) number K770155. The device is classified under product code CJO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALKALINE PHOSPHATASE ISOYZME REAGENT SET?

ALKALINE PHOSPHATASE ISOYZME REAGENT SET is a medical device that received FDA 510(k) clearance on 1977-01-31. The listed applicant is Gelman Instrument Co.. The 510(k) number is K770155.

When did ALKALINE PHOSPHATASE ISOYZME REAGENT SET receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE ISOYZME REAGENT SET received FDA 510(k) clearance on 1977-01-31, under 510(k) number K770155.

Who is the listed applicant for ALKALINE PHOSPHATASE ISOYZME REAGENT SET?

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

What is the FDA product code for ALKALINE PHOSPHATASE ISOYZME REAGENT SET?

The FDA product code for ALKALINE PHOSPHATASE ISOYZME REAGENT SET is CJO.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Gelman Instrument Co. as applicant

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.

K772074RADIAL IMMUNODIFFUSION KIT-TRANSFERRINK772077RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.GK772080RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTITK772076RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.K772079RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.MK772075RADIAL IMMUNODIFFUSION KIT-COMPLEMENT

View all 11 devices →

Related Devices (Code: CJO)

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.

K122323DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPISiemens Healthcare DiagnosticsK121907DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATORSiemens Healthcare DiagnosticsK982328BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.

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.

↑