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FDA 510(k)

EZ-RANGE

K-Number: K941965 · 1995-04-25

ApplicantHematronix, Inc.
Decision Date1995-04-25
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EZ-RANGE is the device name listed in this FDA 510(k) record. The listed applicant is Hematronix, Inc.. It received FDA 510(k) clearance on 1995-04-25 under 510(k) number K941965. 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 EZ-RANGE?

EZ-RANGE is a medical device that received FDA 510(k) clearance on 1995-04-25. The listed applicant is Hematronix, Inc.. The 510(k) number is K941965.

When did EZ-RANGE receive FDA 510(k) clearance?

EZ-RANGE received FDA 510(k) clearance on 1995-04-25, under 510(k) number K941965.

Who is the listed applicant for EZ-RANGE?

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 EZ-RANGE?

The FDA product code for EZ-RANGE is JPK.

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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-TK935343CENTRIFIQ BLOOD CONTROL

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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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