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FDA 510(k)

REP TM SPE (PONCEAU S) PROCEDURES

K-Number: K894585 · 1989-09-13

ApplicantHelena Laboratories
Decision Date1989-09-13
Product CodeCEF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP TM SPE (PONCEAU S) PROCEDURES is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1989-09-13 under 510(k) number K894585. 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 TM SPE (PONCEAU S) PROCEDURES?

REP TM SPE (PONCEAU S) PROCEDURES is a medical device that received FDA 510(k) clearance on 1989-09-13. The listed applicant is Helena Laboratories. The 510(k) number is K894585.

When did REP TM SPE (PONCEAU S) PROCEDURES receive FDA 510(k) clearance?

REP TM SPE (PONCEAU S) PROCEDURES received FDA 510(k) clearance on 1989-09-13, under 510(k) number K894585.

Who is the listed applicant for REP TM SPE (PONCEAU S) PROCEDURES?

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 SPE (PONCEAU S) PROCEDURES?

The FDA product code for REP TM SPE (PONCEAU S) PROCEDURES is CEF.

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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: 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-RadK964453REP 3 FLUR SPE-60 KITHelena LaboratoriesK960029HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KITMorax

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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