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FDA 510(k)

MICRO ELISA MINI READER

K-Number: K800057 · 1980-02-11

ApplicantDynatech Laboratories, Inc.
Decision Date1980-02-11
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICRO ELISA MINI READER 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 1980-02-11 under 510(k) number K800057. 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 MICRO ELISA MINI READER?

MICRO ELISA MINI READER is a medical device that received FDA 510(k) clearance on 1980-02-11. The listed applicant is Dynatech Laboratories, Inc.. The 510(k) number is K800057.

When did MICRO ELISA MINI READER receive FDA 510(k) clearance?

MICRO ELISA MINI READER received FDA 510(k) clearance on 1980-02-11, under 510(k) number K800057.

Who is the listed applicant for MICRO ELISA MINI READER?

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 MICRO ELISA MINI READER?

The FDA product code for MICRO ELISA MINI READER 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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