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FDA 510(k)

SPIFE CK KIT, MODEL 3332, 3333

K-Number: K022757 · 2002-10-11

ApplicantHelena Laboratories
Decision Date2002-10-11
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPIFE CK KIT, MODEL 3332, 3333 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 2002-10-11 under 510(k) number K022757. The device is classified under product code JHY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIFE CK KIT, MODEL 3332, 3333?

SPIFE CK KIT, MODEL 3332, 3333 is a medical device that received FDA 510(k) clearance on 2002-10-11. The listed applicant is Helena Laboratories. The 510(k) number is K022757.

When did SPIFE CK KIT, MODEL 3332, 3333 receive FDA 510(k) clearance?

SPIFE CK KIT, MODEL 3332, 3333 received FDA 510(k) clearance on 2002-10-11, under 510(k) number K022757.

Who is the listed applicant for SPIFE CK KIT, MODEL 3332, 3333?

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

What is the FDA product code for SPIFE CK KIT, MODEL 3332, 3333?

The FDA product code for SPIFE CK KIT, MODEL 3332, 3333 is JHY.

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Other records listing Helena Laboratories 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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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Related Devices (Code: JHY)

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.

K132571ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAYRoche DiagnosticsK070835OLYMPUS CK-MB REAGENTOlympus Life & Material Science Europa GmbH (IrishK022654MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MBRoche Diagnostics Corp.K974421ELECSYS CK-MB STATBoehringer Mannheim Corp.K970343MMB METHODDade Chemistry Systems, Inc.K961412CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITROBayer Corp.

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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