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FDA 510(k)

VITEK GRAM-NEGATIVE IDENTIFICATION CARD

K-Number: K883558 · 1988-09-16

ApplicantVitek Systems, Inc.
Decision Date1988-09-16
Product CodeJSS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VITEK GRAM-NEGATIVE IDENTIFICATION CARD is the device name listed in this FDA 510(k) record. The listed applicant is Vitek Systems, Inc.. It received FDA 510(k) clearance on 1988-09-16 under 510(k) number K883558. The device is classified under product code JSS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITEK GRAM-NEGATIVE IDENTIFICATION CARD?

VITEK GRAM-NEGATIVE IDENTIFICATION CARD is a medical device that received FDA 510(k) clearance on 1988-09-16. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K883558.

When did VITEK GRAM-NEGATIVE IDENTIFICATION CARD receive FDA 510(k) clearance?

VITEK GRAM-NEGATIVE IDENTIFICATION CARD received FDA 510(k) clearance on 1988-09-16, under 510(k) number K883558.

Who is the listed applicant for VITEK GRAM-NEGATIVE IDENTIFICATION CARD?

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

What is the FDA product code for VITEK GRAM-NEGATIVE IDENTIFICATION CARD?

The FDA product code for VITEK GRAM-NEGATIVE IDENTIFICATION CARD is JSS.

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Other records listing Vitek Systems, 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.

K920661VIDAS CMV IGG ASSAYK921302VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK921176VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMK920952VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAYK915884VIDAS CHLAMYDIA ASSAY, MODIFICATIONK905211VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY

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Related Devices (Code: JSS)

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.

K123418GRAM-NEGATIVE QUICKFISH BCAdvandx, Inc.K101558GNR TRAFFIC LIGHT PNA FISHAdvandx, Inc.K092236E.COLI/P. AERUGINOSA PNA FISHAdvandx, Inc.K092393EK/P. AERUGINOSA PNA FISHAdvandx, Inc.K082068E. COLI PNA FISHAdvandx, Inc.K081433EK/P. AERUGINOSA PNA FISHAdvandx, 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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