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FDA 510(k)

IMMUNO-CELL IMMUNO-SEP KIT

K-Number: K812411 · 1981-11-10

ApplicantKallestad Laboratories, Inc.
Decision Date1981-11-10
Product CodeJCF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMMUNO-CELL IMMUNO-SEP 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 1981-11-10 under 510(k) number K812411. The device is classified under product code JCF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNO-CELL IMMUNO-SEP KIT?

IMMUNO-CELL IMMUNO-SEP KIT is a medical device that received FDA 510(k) clearance on 1981-11-10. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K812411.

When did IMMUNO-CELL IMMUNO-SEP KIT receive FDA 510(k) clearance?

IMMUNO-CELL IMMUNO-SEP KIT received FDA 510(k) clearance on 1981-11-10, under 510(k) number K812411.

Who is the listed applicant for IMMUNO-CELL IMMUNO-SEP 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 IMMUNO-CELL IMMUNO-SEP KIT?

The FDA product code for IMMUNO-CELL IMMUNO-SEP KIT is JCF.

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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: JCF)

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.

K911731LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITRBd Becton Dickinson Vacutainer Systems PreanalyticK902445LYMPHO SEP(TM)Icn Biomedicals, Inc.K891407LEUCOPREP CELL SEPARATION TUBEBd Becton Dickinson Vacutainer Systems PreanalyticK874328L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REAE.I. Dupont DE Nemours & Co., Inc.K873185DYNABEADS HLA CELL PREP II ISOLATION PRODUCTDynal Biotech, Inc.K872775LEUCOPREP BRAND TUBEBd Becton Dickinson Vacutainer Systems Preanalytic

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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