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FDA 510(k)

CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER

K-Number: K946387 · 1995-03-30

ApplicantCapintec, Inc.
Decision Date1995-03-30
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Capintec, Inc.. It received FDA 510(k) clearance on 1995-03-30 under 510(k) number K946387. The device is classified under product code JJJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER?

CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER is a medical device that received FDA 510(k) clearance on 1995-03-30. The listed applicant is Capintec, Inc.. The 510(k) number is K946387.

When did CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER receive FDA 510(k) clearance?

CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER received FDA 510(k) clearance on 1995-03-30, under 510(k) number K946387.

Who is the listed applicant for CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER?

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

What is the FDA product code for CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER?

The FDA product code for CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER is JJJ.

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Other records listing Capintec, Inc. as applicant

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K192199CRC PC Smart Chamber K1K162394CRC-77tHRK101452CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TWK071396CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORSK052595CRC 15ULTRAK0301752 BASIC

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Related Devices (Code: JJJ)

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.

K962762SEQUENTIAL SAMPLE MULTI-PHOTON DETECTORBiotraces, Inc.K920559ABBOTT VERTEX ANALYZERAbbott LaboratoriesK900087GENESYS 6000 GAMMA COUNTERLaboratory Technologies, Inc.K896202MATRIX(TM)-96Canberra Industries, Inc.K894902SOURCEREROakfield Instruments, Ltd.K884091SOURCERERJohn Caunt Scientific , 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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