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FDA 510(k)

COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER

K-Number: K850139 · 1985-04-10

ApplicantRapid Diagnostic Laboratories, Inc.
Decision Date1985-04-10
Product CodeKRJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Diagnostic Laboratories, Inc.. It received FDA 510(k) clearance on 1985-04-10 under 510(k) number K850139. The device is classified under product code KRJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER?

COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER is a medical device that received FDA 510(k) clearance on 1985-04-10. The listed applicant is Rapid Diagnostic Laboratories, Inc.. The 510(k) number is K850139.

When did COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER receive FDA 510(k) clearance?

COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER received FDA 510(k) clearance on 1985-04-10, under 510(k) number K850139.

Who is the listed applicant for COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER?

The FDA 510(k) record lists Rapid Diagnostic Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER?

The FDA product code for COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER is KRJ.

Related Clinical Trials

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Other records listing Rapid Diagnostic Laboratories, 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.

K903909BLIND CONTROLS FOR DRUGS OF ABUSE TESTINGK890030NEW LOW LEVEL DRUG MIXTURE CONTROLK875216HIGH PERFORMANCE CALIBRATORSK871694HYPERFORMANCE CONTROLS (HP-CONTROLS)K863117HIGH PERFORMANCE CANNABINOID CONTROLS

Related Devices (Code: KRJ)

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.

K990276POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.K982385POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.K940126AVECOR PRE-BYPASS FILTERAvecor Cardiovascular, Inc.K900672PREBYPASS FILTER, CAT. NO. FPB-5American Omni Medical, Inc.K885154INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEMMedtronic Blood Systems, Inc.K884390INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTERMedtronic Blood Systems, Inc.

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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