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FDA 510(k)

REP(TM) LD-2 STAT KIT, CAT. NO. 3078

K-Number: K892818 · 1989-06-20

ApplicantHelena Laboratories
Decision Date1989-06-20
Product CodeCFE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP(TM) LD-2 STAT KIT, CAT. NO. 3078 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1989-06-20 under 510(k) number K892818. 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 REP(TM) LD-2 STAT KIT, CAT. NO. 3078?

REP(TM) LD-2 STAT KIT, CAT. NO. 3078 is a medical device that received FDA 510(k) clearance on 1989-06-20. The listed applicant is Helena Laboratories. The 510(k) number is K892818.

When did REP(TM) LD-2 STAT KIT, CAT. NO. 3078 receive FDA 510(k) clearance?

REP(TM) LD-2 STAT KIT, CAT. NO. 3078 received FDA 510(k) clearance on 1989-06-20, under 510(k) number K892818.

Who is the listed applicant for REP(TM) LD-2 STAT KIT, CAT. NO. 3078?

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(TM) LD-2 STAT KIT, CAT. NO. 3078?

The FDA product code for REP(TM) LD-2 STAT KIT, CAT. NO. 3078 is CFE.

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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