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FDA 510(k)

MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000)

K-Number: K871415 · 1987-04-22

ApplicantDynatech Laboratories, Inc.
Decision Date1987-04-22
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000) 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 1987-04-22 under 510(k) number K871415. 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 MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000)?

MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000) is a medical device that received FDA 510(k) clearance on 1987-04-22. The listed applicant is Dynatech Laboratories, Inc.. The 510(k) number is K871415.

When did MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000) receive FDA 510(k) clearance?

MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000) received FDA 510(k) clearance on 1987-04-22, under 510(k) number K871415.

Who is the listed applicant for MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000)?

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 MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000)?

The FDA product code for MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000) 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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