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FDA 510(k)

GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90

K-Number: K972576 · 1998-01-22

ApplicantAccumed Intl., Inc.
Decision Date1998-01-22
Product CodeLQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 is the device name listed in this FDA 510(k) record. The listed applicant is Accumed Intl., Inc.. It received FDA 510(k) clearance on 1998-01-22 under 510(k) number K972576. The device is classified under product code LQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90?

GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 is a medical device that received FDA 510(k) clearance on 1998-01-22. The listed applicant is Accumed Intl., Inc.. The 510(k) number is K972576.

When did GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 receive FDA 510(k) clearance?

GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 received FDA 510(k) clearance on 1998-01-22, under 510(k) number K972576.

Who is the listed applicant for GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90?

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

What is the FDA product code for GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90?

The FDA product code for GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 is LQL.

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Other records listing Accumed Intl., 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.

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Related Devices (Code: LQL)

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.

K961968BBLCRYSTAL GRAM-POSITIVE ID SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK961730RAPID GRAM-POSITIVE ID SYSTEMBecton Dickinson Microbiology SystemsK952095VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)Biomerieux Vitek, Inc.K925916VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARDBiomerieux Vitek, Inc.K910304RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIAVitek Systems, Inc.K910537VISI-STREPKev Connecticut Diagnostics, 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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