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FDA 510(k)

TITAN GEL LDH REP SYSTEM

K-Number: K873386 · 1987-10-20

ApplicantHelena Laboratories
Decision Date1987-10-20
Product CodeCFE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TITAN GEL LDH REP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1987-10-20 under 510(k) number K873386. The device is classified under product code CFE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITAN GEL LDH REP SYSTEM?

TITAN GEL LDH REP SYSTEM is a medical device that received FDA 510(k) clearance on 1987-10-20. The listed applicant is Helena Laboratories. The 510(k) number is K873386.

When did TITAN GEL LDH REP SYSTEM receive FDA 510(k) clearance?

TITAN GEL LDH REP SYSTEM received FDA 510(k) clearance on 1987-10-20, under 510(k) number K873386.

Who is the listed applicant for TITAN GEL LDH REP SYSTEM?

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 LDH REP SYSTEM?

The FDA product code for TITAN GEL LDH REP SYSTEM is CFE.

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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: CFE)

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.

K100307GELSCAN, MODEL 1206SebiaK022455SPIFE LD-12 KIT, MODEL 3338Helena LaboratoriesK020467SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452Helena LaboratoriesK970477HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KITSebiaK940224CARDIO REP LDHelena LaboratoriesK921455ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHODE.I. Dupont DE Nemours & Co., 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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