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FDA 510(k)

SERO-STAT STREPTOCOCCUS TEST

K-Number: K790492 · 1979-05-01

ApplicantScott Laboratories, Inc.
Decision Date1979-05-01
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERO-STAT STREPTOCOCCUS TEST is the device name listed in this FDA 510(k) record. The listed applicant is Scott Laboratories, Inc.. It received FDA 510(k) clearance on 1979-05-01 under 510(k) number K790492. 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 SERO-STAT STREPTOCOCCUS TEST?

SERO-STAT STREPTOCOCCUS TEST is a medical device that received FDA 510(k) clearance on 1979-05-01. The listed applicant is Scott Laboratories, Inc.. The 510(k) number is K790492.

When did SERO-STAT STREPTOCOCCUS TEST receive FDA 510(k) clearance?

SERO-STAT STREPTOCOCCUS TEST received FDA 510(k) clearance on 1979-05-01, under 510(k) number K790492.

Who is the listed applicant for SERO-STAT STREPTOCOCCUS TEST?

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

What is the FDA product code for SERO-STAT STREPTOCOCCUS TEST?

The FDA product code for SERO-STAT STREPTOCOCCUS TEST is GTZ.

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Other records listing Scott Laboratories, 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.

K880694B. CAT CONFIRMK874933MUG-INDOLE DISCK874662MYCO-FLUOR REAGENT A & BK873509IDENTICULT-BLK871238ANABAGK863025SERO-STAT R II STAPHYLOCOCCUS 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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