LIQUISPEX(TM) URINE ETHANOL CONTROL— 510(k) K946144
Substantially EquivalentClinical Controls, Inc.
FDA 510(k) clearance K946144 for LIQUISPEX(TM) URINE ETHANOL CONTROL, Substantially Equivalent on 1995-02-08. Applicant: Clinical Controls, Inc.. Device class: 1.
Clearance details
- Applicant
- Clinical Controls, Inc.
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Grover Beach, CA, US
Recent devices under product code JJX
view allMore clearances from Clinical Controls, Inc.
view all- K964278 — WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6
- K962432 — LIQUISPEX URINE (MICRO)ALBUMIN CONTROL
- K955690 — AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3
- K955691 — SERUM VOLATILES CONTROL LEVEL 1 & 2
- K946265 — FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3
Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.