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FDA 510(k)

STREPTOCOCCUS ID TRIPLATE SYSTEM

K-Number: K833254 · 1983-10-28

ApplicantGranite Diagnostics, Inc.
Decision Date1983-10-28
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STREPTOCOCCUS ID TRIPLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Granite Diagnostics, Inc.. It received FDA 510(k) clearance on 1983-10-28 under 510(k) number K833254. The device is classified under product code JSI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STREPTOCOCCUS ID TRIPLATE SYSTEM?

STREPTOCOCCUS ID TRIPLATE SYSTEM is a medical device that received FDA 510(k) clearance on 1983-10-28. The listed applicant is Granite Diagnostics, Inc.. The 510(k) number is K833254.

When did STREPTOCOCCUS ID TRIPLATE SYSTEM receive FDA 510(k) clearance?

STREPTOCOCCUS ID TRIPLATE SYSTEM received FDA 510(k) clearance on 1983-10-28, under 510(k) number K833254.

Who is the listed applicant for STREPTOCOCCUS ID TRIPLATE SYSTEM?

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

What is the FDA product code for STREPTOCOCCUS ID TRIPLATE SYSTEM?

The FDA product code for STREPTOCOCCUS ID TRIPLATE SYSTEM is JSI.

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Other records listing Granite Diagnostics, 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.

K850969INHIBITORY MOLD AGAR PLATEK850970BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORAK832365TCBS AGARK831349STREPTOCOCUS ID PLATEK830252DIPCHEX DIP-SLIDE CULTURE SYSK830251CAMPY BLOOD AGAR PLATE

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Related Devices (Code: JSI)

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.

K070691BBL CHROMAGAR 0157Becton, Dickinson & COK974428DIPSTREAKNovamed , Ltd.K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMOxoid U.S.A., Inc.K890199DENTOCULT SM-STRIP MUTANSOrion Corp.K882182SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326Lakewood Biochemical Co., Inc.K881572XL AGAR BASEAcumedia Manufacturers, 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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