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FDA 510(k)

MICRO ELISA AUTO READER

K-Number: K800522 · 1980-03-25

ApplicantDynatech Laboratories, Inc.
Decision Date1980-03-25
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICRO ELISA AUTO 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 1980-03-25 under 510(k) number K800522. 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 AUTO READER?

MICRO ELISA AUTO READER is a medical device that received FDA 510(k) clearance on 1980-03-25. The listed applicant is Dynatech Laboratories, Inc.. The 510(k) number is K800522.

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

MICRO ELISA AUTO READER received FDA 510(k) clearance on 1980-03-25, under 510(k) number K800522.

Who is the listed applicant for MICRO ELISA AUTO 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 AUTO READER?

The FDA product code for MICRO ELISA AUTO READER is JJQ.

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Other records listing Dynatech Laboratories, Inc. as applicant

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.

K962265MLX MICROTITER PLATE LUMINOMETERK934111MR7000 WITH TIME MANAGER SOFTWARE (TMS)K943701MRX MICROPLATE READERK923456MICROLITE MICROTITER PLATE LUMINOMETER ML3000K915896MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODIK920888MICROLITE MICROTITER PLATE LUMINOMETER ML2200

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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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