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FDA 510(k)

RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.

K-Number: K772076 · 1978-02-03

ApplicantGelman Instrument Co.
Decision Date1978-02-03
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. 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 1978-02-03 under 510(k) number K772076. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.?

RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. is a medical device that received FDA 510(k) clearance on 1978-02-03. The listed applicant is Gelman Instrument Co.. The 510(k) number is K772076.

When did RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. receive FDA 510(k) clearance?

RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. received FDA 510(k) clearance on 1978-02-03, under 510(k) number K772076.

Who is the listed applicant for RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.?

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 RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.?

The FDA product code for RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. is CZP.

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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.

K772078RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBINK772074RADIAL IMMUNODIFFUSION KIT-TRANSFERRINK772077RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.GK772080RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTITK772079RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.MK772075RADIAL IMMUNODIFFUSION KIT-COMPLEMENT

View all 11 devices →

Related Devices (Code: CZP)

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.

K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MHORIBA ABX SASK060130IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENTBeckman Coulter, Inc.K040435ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2Roche Diagnostics Corp.K024038N LATEX IGADade Behring, Inc.K993927WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRADWako Chemicals USA, Inc.K983359IGAAbbott Laboratories

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.

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