URINE SCREENING KIT
FDA 510(k) clearance K830824 · decided 1983-06-12
Clearance details
- K-number
- K830824
- Device name
- URINE SCREENING KIT
- Applicant
- Syn-Kit, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-15
- Decision date
- 1983-06-12
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- CEN
- Device class
- 1
- Regulation number
- 862.1550
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VS-SENSE TEST (K091287) | Common Sense , Ltd. | 2009-08-31 |
| AMNISCREEN HOME DETECTION LINER KIT (K071100) | Common Sense , Ltd. | 2007-10-15 |
| AIMSTICK URINE REAGENT STRIPS (K051727) | Germaine Laboratories, Inc. | 2005-10-26 |
| QUICKVUE ADVANCE PH AND AMINES GLL TEST (K040008) | Quidel Corp. | 2004-04-29 |
| STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS (K030650) | Uridynamics, Inc. | 2003-04-14 |
| FEMEXAM TESTCARD (K962718) | Litmus Concepts, Inc. | 1997-02-07 |
| KYOTEST 5V (K840827) | Kyoto Diagnostics, Inc. | 1984-05-14 |
| HELENA BIOSTRIP PH (K830979) | Helena Laboratories | 1983-05-05 |
| LITH A TEST TM (K830091) | Lenal Creative Approaches, Inc. | 1983-02-15 |
| FOLATE/B12 DUO-BEAD RADIOASSAY (K822241) | Abbott Laboratories | 1982-10-26 |
Recalls involving this device
No recalls on record reference this clearance.