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FDA 510(k)

TITAN GEL HDL CHOLESTEROL KIT

K-Number: K873547 · 1987-10-02

ApplicantHelena Laboratories
Decision Date1987-10-02
Product CodeLBT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TITAN GEL HDL CHOLESTEROL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1987-10-02 under 510(k) number K873547. 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 TITAN GEL HDL CHOLESTEROL KIT?

TITAN GEL HDL CHOLESTEROL KIT is a medical device that received FDA 510(k) clearance on 1987-10-02. The listed applicant is Helena Laboratories. The 510(k) number is K873547.

When did TITAN GEL HDL CHOLESTEROL KIT receive FDA 510(k) clearance?

TITAN GEL HDL CHOLESTEROL KIT received FDA 510(k) clearance on 1987-10-02, under 510(k) number K873547.

Who is the listed applicant for TITAN GEL HDL CHOLESTEROL KIT?

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 TITAN GEL HDL CHOLESTEROL KIT?

The FDA product code for TITAN GEL HDL CHOLESTEROL KIT is LBT.

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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: 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 LaboratoriesK894366REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187Helena LaboratoriesK882368REP HDL ELECTROPHORESIS METHODHelena 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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