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FDA 510(k)

REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083

K-Number: K896170 · 1990-02-16

ApplicantHelena Laboratories
Decision Date1990-02-16
Product CodeJHT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1990-02-16 under 510(k) number K896170. The device is classified under product code JHT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083?

REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 is a medical device that received FDA 510(k) clearance on 1990-02-16. The listed applicant is Helena Laboratories. The 510(k) number is K896170.

When did REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 receive FDA 510(k) clearance?

REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 received FDA 510(k) clearance on 1990-02-16, under 510(k) number K896170.

Who is the listed applicant for REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083?

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 REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083?

The FDA product code for REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 is JHT.

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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: JHT)

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.

K022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTSpectral Diagnostics, Inc.K991299MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBIPrinceton BioMeditech Corp.K930359CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305Helena LaboratoriesK904721DSL CK-MB (DSL #3200)Diagnostic Systems Laboratories, Inc.K904866COULTER CK-MB ISOENZYME REAGENTCoulter Electronics, Inc.K901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MBIntl. Immunoassay Laboratories, Inc.

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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