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FDA 510(k)

BLOOD GAS CONTROL PROD. NO. BG-1, BG-2

K-Number: K801449 · 1980-07-21

ApplicantHealth Diagnostics Corp.
Decision Date1980-07-21
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD GAS CONTROL PROD. NO. BG-1, BG-2 is the device name listed in this FDA 510(k) record. The listed applicant is Health Diagnostics Corp.. It received FDA 510(k) clearance on 1980-07-21 under 510(k) number K801449. 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 BLOOD GAS CONTROL PROD. NO. BG-1, BG-2?

BLOOD GAS CONTROL PROD. NO. BG-1, BG-2 is a medical device that received FDA 510(k) clearance on 1980-07-21. The listed applicant is Health Diagnostics Corp.. The 510(k) number is K801449.

When did BLOOD GAS CONTROL PROD. NO. BG-1, BG-2 receive FDA 510(k) clearance?

BLOOD GAS CONTROL PROD. NO. BG-1, BG-2 received FDA 510(k) clearance on 1980-07-21, under 510(k) number K801449.

Who is the listed applicant for BLOOD GAS CONTROL PROD. NO. BG-1, BG-2?

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

What is the FDA product code for BLOOD GAS CONTROL PROD. NO. BG-1, BG-2?

The FDA product code for BLOOD GAS CONTROL PROD. NO. BG-1, BG-2 is JJS.

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Other records listing Health Diagnostics Corp. 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.

K802334IN-HOME EARLY PREGNANCY TEST KIT

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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