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FDA 510(k)

AMS GRAM-POSITIVE IDENTIFICATION CARD

K-Number: K820264 · 1982-05-03

ApplicantVitek Systems, Inc.
Decision Date1982-05-03
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMS GRAM-POSITIVE 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 1982-05-03 under 510(k) number K820264. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMS GRAM-POSITIVE IDENTIFICATION CARD?

AMS GRAM-POSITIVE IDENTIFICATION CARD is a medical device that received FDA 510(k) clearance on 1982-05-03. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K820264.

When did AMS GRAM-POSITIVE IDENTIFICATION CARD receive FDA 510(k) clearance?

AMS GRAM-POSITIVE IDENTIFICATION CARD received FDA 510(k) clearance on 1982-05-03, under 510(k) number K820264.

Who is the listed applicant for AMS GRAM-POSITIVE 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 AMS GRAM-POSITIVE IDENTIFICATION CARD?

The FDA product code for AMS GRAM-POSITIVE IDENTIFICATION CARD is JTO.

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Other records listing Vitek Systems, Inc. as applicant

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Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, 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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