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FDA 510(k)

GEN-PROBE LUMINOMETER-LEADER 50

K-Number: K903934 · 1990-09-27

ApplicantGen-Probe, Inc.
Decision Date1990-09-27
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEN-PROBE LUMINOMETER-LEADER 50 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 1990-09-27 under 510(k) number K903934. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEN-PROBE LUMINOMETER-LEADER 50?

GEN-PROBE LUMINOMETER-LEADER 50 is a medical device that received FDA 510(k) clearance on 1990-09-27. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K903934.

When did GEN-PROBE LUMINOMETER-LEADER 50 receive FDA 510(k) clearance?

GEN-PROBE LUMINOMETER-LEADER 50 received FDA 510(k) clearance on 1990-09-27, under 510(k) number K903934.

Who is the listed applicant for GEN-PROBE LUMINOMETER-LEADER 50?

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 LUMINOMETER-LEADER 50?

The FDA product code for GEN-PROBE LUMINOMETER-LEADER 50 is JJQ.

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Other records listing Gen-Probe, 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.

K122062APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHERK111409APTIMA COMBO 2 ASSAYK063664GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091K063451GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199K062440GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091K061413APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM

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Related Devices (Code: JJQ)

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.

K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMOtsuka Pharmaceutical Co., Ltd.K980120DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.K974762STAT TRACKSAwareness Technology, Inc.K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.K961183CBI 7520 READERColumbia Bioscience, 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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