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FDA 510(k)

PROTECT T.M.

K-Number: K871121 · 1987-04-14

ApplicantPro-Lab, Inc.
Decision Date1987-04-14
Product CodeJTR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROTECT T.M. is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Lab, Inc.. It received FDA 510(k) clearance on 1987-04-14 under 510(k) number K871121. The device is classified under product code JTR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTECT T.M.?

PROTECT T.M. is a medical device that received FDA 510(k) clearance on 1987-04-14. The listed applicant is Pro-Lab, Inc.. The 510(k) number is K871121.

When did PROTECT T.M. receive FDA 510(k) clearance?

PROTECT T.M. received FDA 510(k) clearance on 1987-04-14, under 510(k) number K871121.

Who is the listed applicant for PROTECT T.M.?

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

What is the FDA product code for PROTECT T.M.?

The FDA product code for PROTECT T.M. is JTR.

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Other records listing Pro-Lab, 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.

K934383PROLEX (STREPTOCCAL GROUPING LATEX KIT)K914419AMNIOTEST(TM)K921421LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODYK903714E. COLI 0157 LATEX TESTK894221ROSCO PYRRK883995X-ACT UREA/TDA

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Related Devices (Code: JTR)

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.

K862914FEKAL CHECK PARASITOLOGY CONTROL SLIDETrend Scientific, Inc.K861022KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-LogicsK855198INDI KWIK (TM) CO/TWO KITMicro-Bio-LogicsK842579B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONSBiological & Environmental Control LaboratoriesK842129LYFO-DISK MICROORGANISMSMicro-Bio-LogicsK831653LYOPHILIZED MICROORGANISMSAustin Biological Laboratories

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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