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FDA 510(k)

QM300 C4 ANTIBODY PACK

K-Number: K872599 · 1987-07-23

ApplicantKallestad Diag, A Div. of Erbamont, Inc.
Decision Date1987-07-23
Product CodeDBI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QM300 C4 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 1987-07-23 under 510(k) number K872599. The device is classified under product code DBI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QM300 C4 ANTIBODY PACK?

QM300 C4 ANTIBODY PACK is a medical device that received FDA 510(k) clearance on 1987-07-23. The listed applicant is Kallestad Diag, A Div. of Erbamont, Inc.. The 510(k) number is K872599.

When did QM300 C4 ANTIBODY PACK receive FDA 510(k) clearance?

QM300 C4 ANTIBODY PACK received FDA 510(k) clearance on 1987-07-23, under 510(k) number K872599.

Who is the listed applicant for QM300 C4 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 C4 ANTIBODY PACK?

The FDA product code for QM300 C4 ANTIBODY PACK is DBI.

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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.

K910886QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACKK910887QM300 CONTROL G PACKK910885QM300 CALIBRATOR G PACKK904725CHLAMYDIA SYSTEM SOFTWARE (CSS)K902253PATHFINDER(TM) CHLAMYDIA MICROPLATE KITK902462MODIFIED QM300 RHEUMATOID FACTOR TEST

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Related Devices (Code: DBI)

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.

K100455SPAPLUS ANALYZERThe Binding SiteK012359TINA-QUANT COMPLEMENT C4 TEST SYSTEMRoche Diagnostics Corp.K010325WAKO AUTOKIT C4Wako Chemicals USA, Inc.K000468RANDOX COMPLEMENT C4Randox Laboratories, Ltd.K994293DIMENSION C4 FLEX REAGENT CARTRIDGEDade Behring, Inc.K981785C4 MININEPH ANTISERUMThe Binding Site, Ltd.

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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