BACTERIURIA DETECT. DEVICE APTEK II— 510(k) K843834

Name: FDA 510(k) clearance K843834
Creator: U.S. Food and Drug Administration
Published: 1984-11-29

Substantially Equivalent

Applied Polytechnology, Inc.

FDA 510(k) clearance K843834 for BACTERIURIA DETECT. DEVICE APTEK II, Substantially Equivalent on 1984-11-29. 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: 1984-10-01
Decision date: 1984-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K860483 — FILTRA-CHECK-UTI1986-04-04
K843833 — BACTERIURIA DETECT DEVICE, MULTI SAMPLER1984-11-29
K843359 — URINE TRANSPORT KIT1984-09-27
K843316 — INDOLE SPOT TEST KIT 270-251984-09-11
K840257 — RAPID IMMUNO-ASSAY SYS1984-04-19

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