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FDA 510(k)

CENTRIFIQ BLOOD CONTROL

K-Number: K935343 · 1994-01-27

ApplicantHematronix, Inc.
Decision Date1994-01-27
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CENTRIFIQ BLOOD CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Hematronix, Inc.. It received FDA 510(k) clearance on 1994-01-27 under 510(k) number K935343. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRIFIQ BLOOD CONTROL?

CENTRIFIQ BLOOD CONTROL is a medical device that received FDA 510(k) clearance on 1994-01-27. The listed applicant is Hematronix, Inc.. The 510(k) number is K935343.

When did CENTRIFIQ BLOOD CONTROL receive FDA 510(k) clearance?

CENTRIFIQ BLOOD CONTROL received FDA 510(k) clearance on 1994-01-27, under 510(k) number K935343.

Who is the listed applicant for CENTRIFIQ BLOOD CONTROL?

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

What is the FDA product code for CENTRIFIQ BLOOD CONTROL?

The FDA product code for CENTRIFIQ BLOOD CONTROL is JPK.

Related Clinical Trials

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Other records listing Hematronix, 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.

K012243MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROLK993496RETIC-QUINOXK972710QUANTIFY(901)K960471TRI-COUNT 20K960005TRI-COURT 20-TK941965EZ-RANGE

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Related Devices (Code: JPK)

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.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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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