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FDA 510(k)

OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561

K-Number: K093280 · 2011-01-07

ApplicantOpti Medical Systems, Inc.
Decision Date2011-01-07
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 is the device name listed in this FDA 510(k) record. The listed applicant is Opti Medical Systems, Inc.. It received FDA 510(k) clearance on 2011-01-07 under 510(k) number K093280. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561?

OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 is a medical device that received FDA 510(k) clearance on 2011-01-07. The listed applicant is Opti Medical Systems, Inc.. The 510(k) number is K093280.

When did OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 receive FDA 510(k) clearance?

OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 received FDA 510(k) clearance on 2011-01-07, under 510(k) number K093280.

Who is the listed applicant for OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561?

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

What is the FDA product code for OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561?

The FDA product code for OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 is CHL.

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 Opti Medical Systems, 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.

K200986OPTI® B-Lac CassetteK131126OPTI CCA-TS2

Related Devices (Code: CHL)

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.

K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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