Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278

K-Number: K930317 · 1993-08-03

ApplicantHelena Laboratories
Decision Date1993-08-03
Product CodeCEF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1993-08-03 under 510(k) number K930317. 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 SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278?

REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 is a medical device that received FDA 510(k) clearance on 1993-08-03. The listed applicant is Helena Laboratories. The 510(k) number is K930317.

When did REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 receive FDA 510(k) clearance?

REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 received FDA 510(k) clearance on 1993-08-03, under 510(k) number K930317.

Who is the listed applicant for REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278?

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 SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278?

The FDA product code for REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 is CEF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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-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.

↑