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FDA 510(k)

WHITSOFT

K-Number: K942361 · 1995-04-04

ApplicantBiowhittaker Molecular Applications, Inc.
Decision Date1995-04-04
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WHITSOFT is the device name listed in this FDA 510(k) record. The listed applicant is Biowhittaker Molecular Applications, Inc.. It received FDA 510(k) clearance on 1995-04-04 under 510(k) number K942361. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WHITSOFT?

WHITSOFT is a medical device that received FDA 510(k) clearance on 1995-04-04. The listed applicant is Biowhittaker Molecular Applications, Inc.. The 510(k) number is K942361.

When did WHITSOFT receive FDA 510(k) clearance?

WHITSOFT received FDA 510(k) clearance on 1995-04-04, under 510(k) number K942361.

Who is the listed applicant for WHITSOFT?

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

What is the FDA product code for WHITSOFT?

The FDA product code for WHITSOFT is JJQ.

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Other records listing Biowhittaker Molecular Applications, 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.

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Related Devices (Code: JJQ)

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.

K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMOtsuka Pharmaceutical Co., Ltd.K980120DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.K974762STAT TRACKSAwareness Technology, Inc.K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.K961183CBI 7520 READERColumbia Bioscience, Inc.

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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