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FDA 510(k)

REP 3 FLUR SPE-60 KIT

K-Number: K964453 · 1996-12-23

ApplicantHelena Laboratories
Decision Date1996-12-23
Product CodeCEF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP 3 FLUR SPE-60 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 1996-12-23 under 510(k) number K964453. The device is classified under product code CEF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REP 3 FLUR SPE-60 KIT?

REP 3 FLUR SPE-60 KIT is a medical device that received FDA 510(k) clearance on 1996-12-23. The listed applicant is Helena Laboratories. The 510(k) number is K964453.

When did REP 3 FLUR SPE-60 KIT receive FDA 510(k) clearance?

REP 3 FLUR SPE-60 KIT received FDA 510(k) clearance on 1996-12-23, under 510(k) number K964453.

Who is the listed applicant for REP 3 FLUR SPE-60 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 REP 3 FLUR SPE-60 KIT?

The FDA product code for REP 3 FLUR SPE-60 KIT is CEF.

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

View all 280 devices →

Related Devices (Code: CEF)

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.

K130500CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENTSebiaK972274SPIFEHelena LaboratoriesK973316REP SPE VIS-60/40 KITHelena LaboratoriesK963018BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESISBio-RadK960029HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KITMoraxK951536HYDRAGEL PROTEIN(E) KITSebia

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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