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FDA 510(k)

BIOSCAN E12

K-Number: K781421 · 1978-09-20

ApplicantClinifax Industries, Ltd.
Decision Date1978-09-20
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOSCAN E12 is the device name listed in this FDA 510(k) record. The listed applicant is Clinifax Industries, Ltd.. It received FDA 510(k) clearance on 1978-09-20 under 510(k) number K781421. The device is classified under product code JJS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSCAN E12?

BIOSCAN E12 is a medical device that received FDA 510(k) clearance on 1978-09-20. The listed applicant is Clinifax Industries, Ltd.. The 510(k) number is K781421.

When did BIOSCAN E12 receive FDA 510(k) clearance?

BIOSCAN E12 received FDA 510(k) clearance on 1978-09-20, under 510(k) number K781421.

Who is the listed applicant for BIOSCAN E12?

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

What is the FDA product code for BIOSCAN E12?

The FDA product code for BIOSCAN E12 is JJS.

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 Clinifax Industries, Ltd. 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.

K780109TILL-U=TEST

Related Devices (Code: JJS)

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.

K152553CueSee HypoxicEurotrol B.V.K130415HIGH METABOLITE QUALICHECKRadiometer Medical ApsK130236RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3Radiometer Medical ApsK033063MISSION CONTROLSDiamond Diagnostics, Inc.K022525LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509Bio-RadK022529LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669Bio-Rad

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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