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FDA 510(k)

GOAT ANTISERUM IGA NEPHELOMETRIC

K-Number: K770962 · 1977-06-24

ApplicantKallestad Laboratories, Inc.
Decision Date1977-06-24
Product CodeCZP
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GOAT ANTISERUM IGA NEPHELOMETRIC is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1977-06-24 under 510(k) number K770962. 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 GOAT ANTISERUM IGA NEPHELOMETRIC?

GOAT ANTISERUM IGA NEPHELOMETRIC is a medical device that received FDA 510(k) clearance on 1977-06-24. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K770962.

When did GOAT ANTISERUM IGA NEPHELOMETRIC receive FDA 510(k) clearance?

GOAT ANTISERUM IGA NEPHELOMETRIC received FDA 510(k) clearance on 1977-06-24, under 510(k) number K770962.

Who is the listed applicant for GOAT ANTISERUM IGA NEPHELOMETRIC?

The FDA 510(k) record lists Kallestad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOAT ANTISERUM IGA NEPHELOMETRIC?

The FDA product code for GOAT ANTISERUM IGA NEPHELOMETRIC is CZP.

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Other records listing Kallestad Laboratories, Inc. as applicant

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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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