Blood Level Detector-Model 7601

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K781330 ↗

FDA Product Code

FJF

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

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  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

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• What is the Blood Level Detector-Model 7601 used for?

  The Blood Level Detector-Model 7601 is designed to identify the presence of air bubbles within blood samples, helping ensure sample integrity in clinical settings where blood analysis is performed.

• How was the Blood Level Detector-Model 7601 authorized for market?

  The Blood Level Detector-Model 7601 was cleared through the FDA 510(k) pathway (K781330) as a Class II device with product code FJF, based on substantial equivalence to a predicate device, with clearance granted on 31 August 1978.

• Which medical specialties is the Blood Level Detector-Model 7601 associated with?

  The Blood Level Detector-Model 7601 is listed under the medical specialties of gastroenterology and urology, as indicated in its FDA 510(k) clearance documentation and OpenFDA classification.