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FDA 510(k)

DIGENE DCR-1 LUMINOMETER

K-Number: K940486 · 1995-04-18

ApplicantDigene Diagnostics, Inc.
Decision Date1995-04-18
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIGENE DCR-1 LUMINOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Digene Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-04-18 under 510(k) number K940486. 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 DIGENE DCR-1 LUMINOMETER?

DIGENE DCR-1 LUMINOMETER is a medical device that received FDA 510(k) clearance on 1995-04-18. The listed applicant is Digene Diagnostics, Inc.. The 510(k) number is K940486.

When did DIGENE DCR-1 LUMINOMETER receive FDA 510(k) clearance?

DIGENE DCR-1 LUMINOMETER received FDA 510(k) clearance on 1995-04-18, under 510(k) number K940486.

Who is the listed applicant for DIGENE DCR-1 LUMINOMETER?

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

What is the FDA product code for DIGENE DCR-1 LUMINOMETER?

The FDA product code for DIGENE DCR-1 LUMINOMETER is JJQ.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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