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FDA 510(k)

DNA STAT TEST KIT

K-Number: K843904 · 1984-11-01

ApplicantWhittaker Bioproducts, Inc.
Decision Date1984-11-01
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DNA STAT TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1984-11-01 under 510(k) number K843904. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DNA STAT TEST KIT?

DNA STAT TEST KIT is a medical device that received FDA 510(k) clearance on 1984-11-01. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K843904.

When did DNA STAT TEST KIT receive FDA 510(k) clearance?

DNA STAT TEST KIT received FDA 510(k) clearance on 1984-11-01, under 510(k) number K843904.

Who is the listed applicant for DNA STAT TEST KIT?

The FDA 510(k) record lists Whittaker Bioproducts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DNA STAT TEST KIT?

The FDA product code for DNA STAT TEST KIT is LJM.

Other records listing Whittaker Bioproducts, Inc. as applicant

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Related Devices (Code: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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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