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FDA 510(k)

EIA (ELISA) READER

K-Number: K791968 · 1979-10-17

ApplicantGilford Instrument Laboratories, Inc.
Decision Date1979-10-17
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EIA (ELISA) READER is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Instrument Laboratories, Inc.. It received FDA 510(k) clearance on 1979-10-17 under 510(k) number K791968. 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 EIA (ELISA) READER?

EIA (ELISA) READER is a medical device that received FDA 510(k) clearance on 1979-10-17. The listed applicant is Gilford Instrument Laboratories, Inc.. The 510(k) number is K791968.

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

EIA (ELISA) READER received FDA 510(k) clearance on 1979-10-17, under 510(k) number K791968.

Who is the listed applicant for EIA (ELISA) READER?

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

What is the FDA product code for EIA (ELISA) READER?

The FDA product code for EIA (ELISA) READER is JJQ.

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Other records listing Gilford Instrument 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.

K823233SBA 300 CLINICAL CHEMISTRY ANALYZERK821583AMES/GILFORD OPTIMATE CLIN. CHEM & THERK802609CHEMISTRY ANALYZER IMPACT 400K801889MODEL 203S CLINICAL CHEMISTRY ANALYZERK800085SYSTEM 203 CHEMISTRY ANALYZERK792361SYSTEM 103 CHEMISTRY ANALYZER

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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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