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FDA 510(k)

OBA(TM) READER

K-Number: K911045 · 1991-06-24

ApplicantAdeza Biomedical
Decision Date1991-06-24
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OBA(TM) READER is the device name listed in this FDA 510(k) record. The listed applicant is Adeza Biomedical. It received FDA 510(k) clearance on 1991-06-24 under 510(k) number K911045. 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 OBA(TM) READER?

OBA(TM) READER is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is Adeza Biomedical. The 510(k) number is K911045.

When did OBA(TM) READER receive FDA 510(k) clearance?

OBA(TM) READER received FDA 510(k) clearance on 1991-06-24, under 510(k) number K911045.

Who is the listed applicant for OBA(TM) READER?

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

What is the FDA product code for OBA(TM) READER?

The FDA product code for OBA(TM) READER is JJQ.

Related Clinical Trials

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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Other records listing Adeza Biomedical 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.

K911047OBA(TM) SERUM HCG ASSAYK900225ROMCHECK SPECIMEN COLLECTION KIT

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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