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FDA 510(k)

TEST, MACROGLOBULIN KIT (ALPHA2)

K-Number: K760396 · 1976-08-26

ApplicantKallestad Laboratories, Inc.
Decision Date1976-08-26
Product Code
DecisionSubstantially Equivalent

Device Summary

TEST, MACROGLOBULIN KIT (ALPHA2) 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 1976-08-26 under 510(k) number K760396. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEST, MACROGLOBULIN KIT (ALPHA2)?

TEST, MACROGLOBULIN KIT (ALPHA2) is a medical device that received FDA 510(k) clearance on 1976-08-26. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K760396.

When did TEST, MACROGLOBULIN KIT (ALPHA2) receive FDA 510(k) clearance?

TEST, MACROGLOBULIN KIT (ALPHA2) received FDA 510(k) clearance on 1976-08-26, under 510(k) number K760396.

Who is the listed applicant for TEST, MACROGLOBULIN KIT (ALPHA2)?

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

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Other records listing Kallestad Laboratories, Inc. 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.

K863681PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMK862917PATHFINDER ROTAVIRUS CHEMILUMINESCENTK863682PATHFINDER(TM) SPECIMEN COLLECTION KITK862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSK862313KALLESTAD SM/RNP TEST REAGENTK862710KALLESTAD SSA/SSB ENA TEST REAGENTS

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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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