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FDA 510(k)

ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY

K-Number: K772246 · 1977-12-22

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

Device Summary

ALPHA-2-MACROGLOBULIN 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 K772246. The device is classified under product code DEB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY?

ALPHA-2-MACROGLOBULIN 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 K772246.

When did ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY receive FDA 510(k) clearance?

ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY received FDA 510(k) clearance on 1977-12-22, under 510(k) number K772246.

Who is the listed applicant for ALPHA-2-MACROGLOBULIN 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 ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY?

The FDA product code for ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY is DEB.

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Other records listing Kallestad Laboratories, Inc. as applicant

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Related Devices (Code: DEB)

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.

K081249DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEMDade Behring, Inc.K053073N ANTISERA TO HUMAN ALPHA2-MACROGLOBULINDade Behring, Inc.K974564IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENTBeckman Instruments, Inc.K914389ALPHA-2 MACROGLOBULIN TEST RID KITThe Binding Site, Ltd.K896483QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.K85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2Kent Laboratories, 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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