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FDA 510(k)

QM300 IGG ANTIBODY PACK

K-Number: K882083 · 1988-07-08

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1988-07-08
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QM300 IGG 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 1988-07-08 under 510(k) number K882083. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QM300 IGG ANTIBODY PACK?

QM300 IGG ANTIBODY PACK is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K882083.

When did QM300 IGG ANTIBODY PACK receive FDA 510(k) clearance?

QM300 IGG ANTIBODY PACK received FDA 510(k) clearance on 1988-07-08, under 510(k) number K882083.

Who is the listed applicant for QM300 IGG 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 IGG ANTIBODY PACK?

The FDA product code for QM300 IGG ANTIBODY PACK is DEW.

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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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Related Devices (Code: DEW)

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.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott Laboratories

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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