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FDA 510(k)

NOVA STREP A

K-Number: K873784 · 1987-11-12

ApplicantSynbiotics Corp.
Decision Date1987-11-12
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NOVA STREP A is the device name listed in this FDA 510(k) record. The listed applicant is Synbiotics Corp.. It received FDA 510(k) clearance on 1987-11-12 under 510(k) number K873784. 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 NOVA STREP A?

NOVA STREP A is a medical device that received FDA 510(k) clearance on 1987-11-12. The listed applicant is Synbiotics Corp.. The 510(k) number is K873784.

When did NOVA STREP A receive FDA 510(k) clearance?

NOVA STREP A received FDA 510(k) clearance on 1987-11-12, under 510(k) number K873784.

Who is the listed applicant for NOVA STREP A?

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

What is the FDA product code for NOVA STREP A?

The FDA product code for NOVA STREP A is GTZ.

Related Clinical Trials

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.

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Other records listing Synbiotics Corp. 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.

K883235RAPIDTEST-HCG (TM)K862354MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT

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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