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FDA 510(k)

QUANTIMETRIC PLUS C4 REAGENT KIT

K-Number: K855012 · 1986-02-26

ApplicantKallestad Laboratories, Inc.
Decision Date1986-02-26
Product CodeDBI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTIMETRIC PLUS C4 REAGENT KIT 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 1986-02-26 under 510(k) number K855012. 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 QUANTIMETRIC PLUS C4 REAGENT KIT?

QUANTIMETRIC PLUS C4 REAGENT KIT is a medical device that received FDA 510(k) clearance on 1986-02-26. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K855012.

When did QUANTIMETRIC PLUS C4 REAGENT KIT receive FDA 510(k) clearance?

QUANTIMETRIC PLUS C4 REAGENT KIT received FDA 510(k) clearance on 1986-02-26, under 510(k) number K855012.

Who is the listed applicant for QUANTIMETRIC PLUS C4 REAGENT KIT?

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 QUANTIMETRIC PLUS C4 REAGENT KIT?

The FDA product code for QUANTIMETRIC PLUS C4 REAGENT KIT is DBI.

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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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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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