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FDA 510(k)

PROLEX (STREPTOCCAL GROUPING LATEX KIT)

K-Number: K934383 · 1995-01-27

ApplicantPro-Lab, Inc.
Decision Date1995-01-27
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROLEX (STREPTOCCAL GROUPING LATEX KIT) 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 1995-01-27 under 510(k) number K934383. The device is classified under product code GTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROLEX (STREPTOCCAL GROUPING LATEX KIT)?

PROLEX (STREPTOCCAL GROUPING LATEX KIT) is a medical device that received FDA 510(k) clearance on 1995-01-27. The listed applicant is Pro-Lab, Inc.. The 510(k) number is K934383.

When did PROLEX (STREPTOCCAL GROUPING LATEX KIT) receive FDA 510(k) clearance?

PROLEX (STREPTOCCAL GROUPING LATEX KIT) received FDA 510(k) clearance on 1995-01-27, under 510(k) number K934383.

Who is the listed applicant for PROLEX (STREPTOCCAL GROUPING LATEX KIT)?

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 PROLEX (STREPTOCCAL GROUPING LATEX KIT)?

The FDA product code for PROLEX (STREPTOCCAL GROUPING LATEX KIT) is GTZ.

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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.

K914419AMNIOTEST(TM)K921421LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODYK903714E. COLI 0157 LATEX TESTK894221ROSCO PYRRK883996X-ACT LDC/INDK883995X-ACT UREA/TDA

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Related Devices (Code: GTZ)

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.

K012521BINAX NOW STREPTOCOCCUS PNEUMONIAE TESTBinax, Inc.K011709UNI-GOLD STREP A TEST KITTrinity Biotech, PlcK010523MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TESTBinax, Inc.K991726BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONIBinax, Inc.K971522ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) IIAbbott LaboratoriesK962060STREP A OIA MAXBiostar, 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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