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FDA 510(k)

EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT

K-Number: K962146 · 1996-10-07

ApplicantExcel Scientific, Inc.
Decision Date1996-10-07
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Excel Scientific, Inc.. It received FDA 510(k) clearance on 1996-10-07 under 510(k) number K962146. 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 EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT?

EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT is a medical device that received FDA 510(k) clearance on 1996-10-07. The listed applicant is Excel Scientific, Inc.. The 510(k) number is K962146.

When did EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT receive FDA 510(k) clearance?

EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT received FDA 510(k) clearance on 1996-10-07, under 510(k) number K962146.

Who is the listed applicant for EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT?

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

What is the FDA product code for EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT?

The FDA product code for EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT is GTZ.

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Other records listing Excel Scientific, 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.

K971286EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TESTK970467EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KITK970424EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TESTK970425EZ SURE URINE DIPSTICK PREGNANCY HOME TESTK963231EXCEL ONESTEP URINE HCG MODULE PREGNANCY TESTK962580EZ SURE ONESTEP EARLY PREGNANCY TEST

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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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