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FDA 510(k)

MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER

K-Number: K895313 · 1989-10-17

ApplicantDynatech Laboratories, Inc.
Decision Date1989-10-17
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech Laboratories, Inc.. It received FDA 510(k) clearance on 1989-10-17 under 510(k) number K895313. 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 MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER?

MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER is a medical device that received FDA 510(k) clearance on 1989-10-17. The listed applicant is Dynatech Laboratories, Inc.. The 510(k) number is K895313.

When did MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER receive FDA 510(k) clearance?

MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER received FDA 510(k) clearance on 1989-10-17, under 510(k) number K895313.

Who is the listed applicant for MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER?

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

What is the FDA product code for MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER?

The FDA product code for MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER is JJQ.

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Other records listing Dynatech Laboratories, Inc. as applicant

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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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