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FDA 510(k)

OIA STREP A

K-Number: K912889 · 1991-10-31

ApplicantBiosearch Medical Products, Inc.
Decision Date1991-10-31
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OIA STREP A is the device name listed in this FDA 510(k) record. The listed applicant is Biosearch Medical Products, Inc.. It received FDA 510(k) clearance on 1991-10-31 under 510(k) number K912889. 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 OIA STREP A?

OIA STREP A is a medical device that received FDA 510(k) clearance on 1991-10-31. The listed applicant is Biosearch Medical Products, Inc.. The 510(k) number is K912889.

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

OIA STREP A received FDA 510(k) clearance on 1991-10-31, under 510(k) number K912889.

Who is the listed applicant for OIA STREP A?

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

What is the FDA product code for OIA STREP A?

The FDA product code for OIA STREP A is GTZ.

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Other records listing Biosearch Medical Products, 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.

K051480ENTERAL FEEDING TUBEK970145PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)K964871BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTSK951260URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANTK944614MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEMK932295NON-BALLOON REPLACEMENT GASTROSTOMY KIT

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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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