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FDA 510(k)

MICROTRAK EIA AUTOREADER

K-Number: K891270 · 1989-06-16

ApplicantSyva Co.
Decision Date1989-06-16
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICROTRAK EIA AUTOREADER is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1989-06-16 under 510(k) number K891270. 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 MICROTRAK EIA AUTOREADER?

MICROTRAK EIA AUTOREADER is a medical device that received FDA 510(k) clearance on 1989-06-16. The listed applicant is Syva Co.. The 510(k) number is K891270.

When did MICROTRAK EIA AUTOREADER receive FDA 510(k) clearance?

MICROTRAK EIA AUTOREADER received FDA 510(k) clearance on 1989-06-16, under 510(k) number K891270.

Who is the listed applicant for MICROTRAK EIA AUTOREADER?

The FDA 510(k) record lists Syva Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROTRAK EIA AUTOREADER?

The FDA product code for MICROTRAK EIA AUTOREADER is JJQ.

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Other records listing Syva Co. 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.

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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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