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FDA 510(k)

QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT

K-Number: K852999 · 1985-10-21

ApplicantKallestad Laboratories, Inc.
Decision Date1985-10-21
Product CodeDEH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QVANTIMETRIC 2KAPPA AND LAMBDA TEST 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 1985-10-21 under 510(k) number K852999. The device is classified under product code DEH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT?

QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT is a medical device that received FDA 510(k) clearance on 1985-10-21. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K852999.

When did QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT receive FDA 510(k) clearance?

QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT received FDA 510(k) clearance on 1985-10-21, under 510(k) number K852999.

Who is the listed applicant for QVANTIMETRIC 2KAPPA AND LAMBDA TEST 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 QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT?

The FDA product code for QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT is DEH.

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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: DEH)

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.

K172471VENTANA CD30 (Ber-H2) RxDx AssayVentana Medical Systems, Inc.K083601LAMBDA LIGHT CHAINSSENTINEL CH. SpAK033811FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZERThe Binding Site, Ltd.K031016FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER IIThe Binding Site, Ltd.K023131FREELITE HUMAN LAMBDA FREE KITThe Binding Site, Ltd.K010440FREELITE LAMBDA FREE KITThe 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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