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FDA 510(k)

REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187

K-Number: K894366 · 1989-08-31

ApplicantHelena Laboratories
Decision Date1989-08-31
Product CodeLBT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1989-08-31 under 510(k) number K894366. The device is classified under product code LBT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187?

REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 is a medical device that received FDA 510(k) clearance on 1989-08-31. The listed applicant is Helena Laboratories. The 510(k) number is K894366.

When did REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 receive FDA 510(k) clearance?

REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 received FDA 510(k) clearance on 1989-08-31, under 510(k) number K894366.

Who is the listed applicant for REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187?

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-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187?

The FDA product code for REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 is LBT.

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: LBT)

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.

K000568HDL CHOLESTEROL PLUSRoche Diagnostics Corp.K990250HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0MoraxK972015HYDRAGEL 7,15,30, CHOL-HDL KITMoraxK904035REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEMHelena LaboratoriesK882368REP HDL ELECTROPHORESIS METHODHelena LaboratoriesK873547TITAN GEL HDL CHOLESTEROL KITHelena Laboratories

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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