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FDA 510(k)

IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)

K-Number: K972861 · 1997-08-19

ApplicantInstrumentation Laboratory CO
Decision Date1997-08-19
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1997-08-19 under 510(k) number K972861. 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 IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)?

IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) is a medical device that received FDA 510(k) clearance on 1997-08-19. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K972861.

When did IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) receive FDA 510(k) clearance?

IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) received FDA 510(k) clearance on 1997-08-19, under 510(k) number K972861.

Who is the listed applicant for IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)?

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

What is the FDA product code for IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)?

The FDA product code for IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) is JJS.

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Other records listing Instrumentation Laboratory CO 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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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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

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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