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FDA 510(k)

NEPHELRATE ANTISERUMS 1GA

K-Number: K781655 · 1978-11-08

ApplicantAntibodies, Inc.
Decision Date1978-11-08
Product CodeCFN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NEPHELRATE ANTISERUMS 1GA is the device name listed in this FDA 510(k) record. The listed applicant is Antibodies, Inc.. It received FDA 510(k) clearance on 1978-11-08 under 510(k) number K781655. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEPHELRATE ANTISERUMS 1GA?

NEPHELRATE ANTISERUMS 1GA is a medical device that received FDA 510(k) clearance on 1978-11-08. The listed applicant is Antibodies, Inc.. The 510(k) number is K781655.

When did NEPHELRATE ANTISERUMS 1GA receive FDA 510(k) clearance?

NEPHELRATE ANTISERUMS 1GA received FDA 510(k) clearance on 1978-11-08, under 510(k) number K781655.

Who is the listed applicant for NEPHELRATE ANTISERUMS 1GA?

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

What is the FDA product code for NEPHELRATE ANTISERUMS 1GA?

The FDA product code for NEPHELRATE ANTISERUMS 1GA is CFN.

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Other records listing Antibodies, Inc. as applicant

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K890774GIARDEIA(TM)K843590DETECT-A-STREPK822892CORTISOL RIA KITK812749ULTRA-DIGK812314CRITHIDNA ANTI-DNA TEST KITK802877AMIKACIN RIA KIT

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Related Devices (Code: CFN)

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.

K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbHK221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group , Ltd.K191985Optilite IgA KitThe Binding Site Group , Ltd.K191635Optilite IgM KitThe Binding Site Group , Ltd.K191465Human IgM Kit for use on SPAPlusThe Binding Site Group , Ltd.

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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