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FDA 510(k)

SEROIDEN STREPTO KIT 'EIKEN'

K-Number: K861098 · 1986-08-12

ApplicantSyn-Kit, Inc.
Decision Date1986-08-12
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SEROIDEN STREPTO KIT 'EIKEN' is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1986-08-12 under 510(k) number K861098. 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 SEROIDEN STREPTO KIT 'EIKEN'?

SEROIDEN STREPTO KIT 'EIKEN' is a medical device that received FDA 510(k) clearance on 1986-08-12. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K861098.

When did SEROIDEN STREPTO KIT 'EIKEN' receive FDA 510(k) clearance?

SEROIDEN STREPTO KIT 'EIKEN' received FDA 510(k) clearance on 1986-08-12, under 510(k) number K861098.

Who is the listed applicant for SEROIDEN STREPTO KIT 'EIKEN'?

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

What is the FDA product code for SEROIDEN STREPTO KIT 'EIKEN'?

The FDA product code for SEROIDEN STREPTO KIT 'EIKEN' is GTZ.

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Other records listing Syn-Kit, 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.

K861631SLIDE CULTURE U 'EIKEN'K854819CPR SLIDE EIKENK854820RA 80 EIKENK853276ASO SLIDE EIKENK843758UROPAPER EIKEN GKK843753UROPAPER EIKEN GP

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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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