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FDA 510(k)

CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION

K-Number: K870561 · 1987-04-21

ApplicantDiversified Diagnostic Industries
Decision Date1987-04-21
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION is the device name listed in this FDA 510(k) record. The listed applicant is Diversified Diagnostic Industries. It received FDA 510(k) clearance on 1987-04-21 under 510(k) number K870561. 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 CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION?

CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION is a medical device that received FDA 510(k) clearance on 1987-04-21. The listed applicant is Diversified Diagnostic Industries. The 510(k) number is K870561.

When did CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION receive FDA 510(k) clearance?

CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION received FDA 510(k) clearance on 1987-04-21, under 510(k) number K870561.

Who is the listed applicant for CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION?

The FDA 510(k) record lists Diversified Diagnostic Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION?

The FDA product code for CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION is JTO.

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Other records listing Diversified Diagnostic Industries 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.

K870410CHROMAGEN TEST FOR GROUP D ENTEROCOCCUSK870409CHROMAGEN TEST FOR GROUP A STREP

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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