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FDA 510(k)

REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181

K-Number: K893223 · 1989-06-09

ApplicantHelena Laboratories
Decision Date1989-06-09
Product CodeJHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1989-06-09 under 510(k) number K893223. 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 LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181?

REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 is a medical device that received FDA 510(k) clearance on 1989-06-09. The listed applicant is Helena Laboratories. The 510(k) number is K893223.

When did REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 receive FDA 510(k) clearance?

REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 received FDA 510(k) clearance on 1989-06-09, under 510(k) number K893223.

Who is the listed applicant for REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181?

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 LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181?

The FDA product code for REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 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 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: JHO)

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.

K022333SPIFE LIPPOROTEIN-12, MODEL 3344Helena LaboratoriesK022053HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134SebiaK013662MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix Corp.K012789MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123MoraxK013466SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343Helena LaboratoriesK010337LIPOPRINT 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.

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