FILTRA-CHECK-UTI— 510(k) K860483

Substantially Equivalent

Applied Polytechnology, Inc.

FDA 510(k) clearance K860483 for FILTRA-CHECK-UTI, Substantially Equivalent on 1986-04-04. Applicant: Applied Polytechnology, Inc.. Device class: 1.

Clearance details

Applicant: Applied Polytechnology, Inc.
Product code: Code JXA
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1986-02-10
Decision date: 1986-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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Recent devices under product code JXA

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K950257 — MULTIPLE (IZON DBS & URINE COLLECTION KIT)1995-04-14

More clearances from Applied Polytechnology, Inc.

K843833 — BACTERIURIA DETECT DEVICE, MULTI SAMPLER1984-11-29
K843834 — BACTERIURIA DETECT. DEVICE APTEK II1984-11-29
K843359 — URINE TRANSPORT KIT1984-09-27
K843316 — INDOLE SPOT TEST KIT 270-251984-09-11
K840257 — RAPID IMMUNO-ASSAY SYS1984-04-19

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