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FDA 510(k)

DIGENE DML 2000 MICROPLATE LUMINOMETER

K-Number: K980120 · 1998-02-06

ApplicantDigene Corp.
Decision Date1998-02-06
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIGENE DML 2000 MICROPLATE LUMINOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Digene Corp.. It received FDA 510(k) clearance on 1998-02-06 under 510(k) number K980120. 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 DML 2000 MICROPLATE LUMINOMETER?

DIGENE DML 2000 MICROPLATE LUMINOMETER is a medical device that received FDA 510(k) clearance on 1998-02-06. The listed applicant is Digene Corp.. The 510(k) number is K980120.

When did DIGENE DML 2000 MICROPLATE LUMINOMETER receive FDA 510(k) clearance?

DIGENE DML 2000 MICROPLATE LUMINOMETER received FDA 510(k) clearance on 1998-02-06, under 510(k) number K980120.

Who is the listed applicant for DIGENE DML 2000 MICROPLATE LUMINOMETER?

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

What is the FDA product code for DIGENE DML 2000 MICROPLATE LUMINOMETER?

The FDA product code for DIGENE DML 2000 MICROPLATE 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.

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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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