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FDA 510(k)

QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK

K-Number: K894538 · 1989-08-04

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1989-08-04
Product CodeDBN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. It received FDA 510(k) clearance on 1989-08-04 under 510(k) number K894538. The device is classified under product code DBN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK?

QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK is a medical device that received FDA 510(k) clearance on 1989-08-04. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K894538.

When did QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK receive FDA 510(k) clearance?

QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK received FDA 510(k) clearance on 1989-08-04, under 510(k) number K894538.

Who is the listed applicant for QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK?

The FDA 510(k) record lists Kallestad Diag, A Div. of Erbamont, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK?

The FDA product code for QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK is DBN.

Related Clinical Trials

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.

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Other records listing Kallestad Diag, A Div. of Erbamont, 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.

K910887QM300 CONTROL G PACKK910886QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACKK910885QM300 CALIBRATOR G PACKK904725CHLAMYDIA SYSTEM SOFTWARE (CSS)K902253PATHFINDER(TM) CHLAMYDIA MICROPLATE KITK902462MODIFIED QM300 RHEUMATOID FACTOR TEST

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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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