FDA Product Code
FDA Product Code CEN — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1550
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K091287 | VS-SENSE TEST | Common Sense , Ltd. | 2009-08-31 | Traditional | PDF ↗ |
| K071100 | AMNISCREEN HOME DETECTION LINER KIT | Common Sense , Ltd. | 2007-10-15 | Traditional | PDF ↗ |
| K051727 | AIMSTICK URINE REAGENT STRIPS | Germaine Laboratories, Inc. | 2005-10-26 | Traditional | PDF ↗ |
| K040008 | QUICKVUE ADVANCE PH AND AMINES GLL TEST | Quidel Corp. | 2004-04-29 | Traditional | PDF ↗ |
| K030650 | STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS | Uridynamics, Inc. | 2003-04-14 | Traditional | PDF ↗ |
| K962718 | FEMEXAM TESTCARD | Litmus Concepts, Inc. | 1997-02-07 | Traditional | PDF ↗ |
| K840827 | KYOTEST 5V | Kyoto Diagnostics, Inc. | 1984-05-14 | Traditional | PDF ↗ |
| K830824 | URINE SCREENING KIT | Syn-Kit, Inc. | 1983-06-12 | Traditional | PDF ↗ |
| K830979 | HELENA BIOSTRIP PH | Helena Laboratories | 1983-05-05 | Traditional | PDF ↗ |
| K830091 | LITH A TEST TM | Lenal Creative Approaches, Inc. | 1983-02-15 | Traditional | PDF ↗ |
| K822241 | FOLATE/B12 DUO-BEAD RADIOASSAY | Abbott Laboratories | 1982-10-26 | Traditional | PDF ↗ |
Product code CEN · Class I · Clinical Chemistry. Data: openFDA.