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FDA 510(k)

GEN-PROBE LUMINOMETER-LEADER 450

K-Number: K905762 · 1991-01-23

ApplicantGen-Probe, Inc.
Decision Date1991-01-23
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEN-PROBE LUMINOMETER-LEADER 450 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 1991-01-23 under 510(k) number K905762. 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 450?

GEN-PROBE LUMINOMETER-LEADER 450 is a medical device that received FDA 510(k) clearance on 1991-01-23. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K905762.

When did GEN-PROBE LUMINOMETER-LEADER 450 receive FDA 510(k) clearance?

GEN-PROBE LUMINOMETER-LEADER 450 received FDA 510(k) clearance on 1991-01-23, under 510(k) number K905762.

Who is the listed applicant for GEN-PROBE LUMINOMETER-LEADER 450?

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 450?

The FDA product code for GEN-PROBE LUMINOMETER-LEADER 450 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.

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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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