FDA 510(k)

REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222

K-Number: K940679 · 1994-09-09

Decision Date1994-09-09

Product CodeJHO

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1994-09-09 under 510(k) number K940679. The device is classified under product code JHO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222?

REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 is a medical device that received FDA 510(k) clearance on 1994-09-09. The listed applicant is Helena Laboratories. The 510(k) number is K940679.

When did REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 receive FDA 510(k) clearance?

REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 received FDA 510(k) clearance on 1994-09-09, under 510(k) number K940679.

Who is the listed applicant for REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222?

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 HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222?

The FDA product code for REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 is JHO.

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 CONTROL K100103SPECIALTY ASSAYED CONTROL-2 K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA K061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP K050053HEMORAM/AGGRAM ANALYZER

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Related Devices (Code: JHO)

K022333SPIFE LIPPOROTEIN-12, MODEL 3344Helena Laboratories K022053HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134Sebia K013662MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix Corp.K012789MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123Morax K013466SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343Helena Laboratories K010337LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix 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.