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FDA 510(k)

GEN-PROBE BETA-LACTAMASE TEST KIT

K-Number: K870422 · 1987-04-21

ApplicantGen-Probe, Inc.
Decision Date1987-04-21
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GEN-PROBE BETA-LACTAMASE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe, Inc.. It received FDA 510(k) clearance on 1987-04-21 under 510(k) number K870422. 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 GEN-PROBE BETA-LACTAMASE TEST KIT?

GEN-PROBE BETA-LACTAMASE TEST KIT is a medical device that received FDA 510(k) clearance on 1987-04-21. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K870422.

When did GEN-PROBE BETA-LACTAMASE TEST KIT receive FDA 510(k) clearance?

GEN-PROBE BETA-LACTAMASE TEST KIT received FDA 510(k) clearance on 1987-04-21, under 510(k) number K870422.

Who is the listed applicant for GEN-PROBE BETA-LACTAMASE TEST KIT?

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

What is the FDA product code for GEN-PROBE BETA-LACTAMASE TEST KIT?

The FDA product code for GEN-PROBE BETA-LACTAMASE TEST KIT is JTO.

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Other records listing Gen-Probe, 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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