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FDA 510(k)

AUTO-EIA

K-Number: K873583 · 1987-09-22

ApplicantLabsystems, Inc.
Decision Date1987-09-22
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTO-EIA is the device name listed in this FDA 510(k) record. The listed applicant is Labsystems, Inc.. It received FDA 510(k) clearance on 1987-09-22 under 510(k) number K873583. 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 AUTO-EIA?

AUTO-EIA is a medical device that received FDA 510(k) clearance on 1987-09-22. The listed applicant is Labsystems, Inc.. The 510(k) number is K873583.

When did AUTO-EIA receive FDA 510(k) clearance?

AUTO-EIA received FDA 510(k) clearance on 1987-09-22, under 510(k) number K873583.

Who is the listed applicant for AUTO-EIA?

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

What is the FDA product code for AUTO-EIA?

The FDA product code for AUTO-EIA is JJQ.

Other records listing Labsystems, 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.

K923365TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEMK896474RESUBMITTED FECATWIN SENSITIVE - FECA-EIAK890154MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIAK890091MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KITK881243RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201K873780MODIFICATION RUBELLA IGM EIA TEST KIT

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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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