ON THE SPOT CANDIDASURE— 510(k) K883118

Substantially Equivalent

Medi-Tech, Inc.

FDA 510(k) clearance K883118 for ON THE SPOT CANDIDASURE, Substantially Equivalent on 1988-09-30. Applicant: Medi-Tech, Inc.. Device class: 2.

Clearance details

Applicant: Medi-Tech, Inc.
Product code: Code LRF
Device class: Class 2
Regulation: 21 CFR 866.3165
Advisory panel: Microbiology
Date received: 1988-07-25
Decision date: 1988-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRF

K863499 — CANDIDATE(R) SUPER1987-03-19
K843286 — EI-CANDIDA ENZYME IMMUNOASSAY EI10011984-10-01

More clearances from Medi-Tech, Inc.

K954457 — MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER1996-05-15
K952345 — MEDI-TECH PLATFORM GUIDE CATHETER1995-08-17
K952056 — IMMUNOASSAY DRUGS OF ABUSE CONTROLS1995-06-01
K945289 — DOA - IMMUNOASSAY CUT-OFF CALIBRATOR1994-12-13
K942551 — THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED1994-10-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.