CONTROLCHEK II(TM)— 510(k) K873034

Name: FDA 510(k) clearance K873034
Creator: U.S. Food and Drug Administration
Published: 1987-08-19

Substantially Equivalent

Petra Biomedical Products, Inc.

FDA 510(k) clearance K873034 for CONTROLCHEK II(TM), Substantially Equivalent on 1987-08-19. Applicant: Petra Biomedical Products, Inc.. Device class: 1.

Clearance details

Applicant: Petra Biomedical Products, Inc.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1987-08-05
Decision date: 1987-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tulsa, OK, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTO

view all

K050352 — IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT2005-09-01
K970832 — PYR SWAB1997-04-24
K970834 — GRAM SWAB1997-04-17
K970833 — INDOLE SWAB1997-04-02
K970009 — LYFO(TM) DIFFERENTIAL DISK-BACITRACIN1997-02-06

More clearances from Petra Biomedical Products, Inc.

view all

K871445 — CONTROLCHEK(TM)1987-04-29
K833612 — FLUOR-B. FRAG. DIRECT FLUORESCENT ANTI1983-12-12
K833613 — FLUOR-B MEL A DIRECT FLUORESCENT ANTI1983-12-12

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