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FDA 510(k)

STREPTO-SEC TM

K-Number: K801159 · 1980-06-20

ApplicantOrganon, Inc.
Decision Date1980-06-20
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STREPTO-SEC TM is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1980-06-20 under 510(k) number K801159. 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 STREPTO-SEC TM?

STREPTO-SEC TM is a medical device that received FDA 510(k) clearance on 1980-06-20. The listed applicant is Organon, Inc.. The 510(k) number is K801159.

When did STREPTO-SEC TM receive FDA 510(k) clearance?

STREPTO-SEC TM received FDA 510(k) clearance on 1980-06-20, under 510(k) number K801159.

Who is the listed applicant for STREPTO-SEC TM?

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

What is the FDA product code for STREPTO-SEC TM?

The FDA product code for STREPTO-SEC TM is GTZ.

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Other records listing Organon, Inc. as applicant

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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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