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FDA 510(k)

QUANTIFY(901)

K-Number: K972710 · 1997-08-15

ApplicantHematronix, Inc.
Decision Date1997-08-15
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIFY(901) is the device name listed in this FDA 510(k) record. The listed applicant is Hematronix, Inc.. It received FDA 510(k) clearance on 1997-08-15 under 510(k) number K972710. The device is classified under product code JJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIFY(901)?

QUANTIFY(901) is a medical device that received FDA 510(k) clearance on 1997-08-15. The listed applicant is Hematronix, Inc.. The 510(k) number is K972710.

When did QUANTIFY(901) receive FDA 510(k) clearance?

QUANTIFY(901) received FDA 510(k) clearance on 1997-08-15, under 510(k) number K972710.

Who is the listed applicant for QUANTIFY(901)?

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 QUANTIFY(901)?

The FDA product code for QUANTIFY(901) is JJW.

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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-QUINOXK960471TRI-COUNT 20K960005TRI-COURT 20-TK941965EZ-RANGEK935343CENTRIFIQ BLOOD CONTROL

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Related Devices (Code: JJW)

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.

K170091UA-Cellular CompleteStreckK110846RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2Randox Laboratories LimitedK103387MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLACON Laboratories, Inc.K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2Cliniqa CorporationK072640IRISPEC,CA/CB/CCIris DiagnosticsK070848LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435XBio-Rad, Diagnostics Grp.

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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