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FDA 510(k)

IMMUNOGLOBULIN M NEPHEL. ASSAY

K-Number: K772254 · 1977-12-22

ApplicantKallestad Laboratories, Inc.
Decision Date1977-12-22
Product CodeDFT
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOGLOBULIN M NEPHEL. ASSAY 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 1977-12-22 under 510(k) number K772254. The device is classified under product code DFT. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOGLOBULIN M NEPHEL. ASSAY?

IMMUNOGLOBULIN M NEPHEL. ASSAY is a medical device that received FDA 510(k) clearance on 1977-12-22. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K772254.

When did IMMUNOGLOBULIN M NEPHEL. ASSAY receive FDA 510(k) clearance?

IMMUNOGLOBULIN M NEPHEL. ASSAY received FDA 510(k) clearance on 1977-12-22, under 510(k) number K772254.

Who is the listed applicant for IMMUNOGLOBULIN M NEPHEL. ASSAY?

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 IMMUNOGLOBULIN M NEPHEL. ASSAY?

The FDA product code for IMMUNOGLOBULIN M NEPHEL. ASSAY is DFT.

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Other records listing Kallestad Laboratories, Inc. as applicant

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Related Devices (Code: DFT)

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.

K983132IGMAbbott LaboratoriesK962201QUANTEX IGMInstrumentation Laboratory COK955797IGM IMMUNOTRUBIDIMETRIC & CALIBRATORRandox Laboratories, Ltd.K945522I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLSBeckman-Diagnostic Systems GroupK901453QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHODIsolab, Inc.K894417RAICHEM(TM) SPIA(TM) IGM REAGENTSReagents Applications, 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.

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