510(k) K040008
- Device
- QUICKVUE ADVANCE PH AND AMINES GLL TEST
- Applicant
- QUIDEL CORP.
- 510(k) number
- K040008
- Product code
- CEN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-04-29
- Date received
- 2004-01-02
- Regulation
- 862.1550
- Classification name
- Dye-indicator, Ph (urinary, Non-quantitative)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JENNIFER S HANKARD
- Address
- 10165 Mckellar Ct. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3038206980
- 8040374
- 3043127647
- 3003422726
- 3012706495
- 3011689956
- 3021186226
- 3034669683
- 3004192065
- 3005841640
- 3009238284
- 8030124
- 9615507
- 3010143501
- 3042471840
- 1719513
- 3027519599
- 3006198300
- 3009448641
- 3013545943
- 9610633
- 9680746
- 1649661
- 3030230672
- 3008987086
- 9710094
- 1616487
- 1417592
- 3008058135
- 9611444
- 3030648160
- 4580
- 2183416
- 3007301207
- 2029372
- 9610126
- 3043127699
- 3003795116
- 1036362
- 2244821
- 3010324880
- 1181121
- 3010891909
- 3008517993
- 1832816
- 3005360469
- 3012073813
- 3015341499
- 3002637618
- 3006621318
- 3008163531
- 1832216
- 3030446844
- 3012421607
- 3013679502
- 3024463179
- 3024171133
- 3012494290
- 1061932
- 2122870
- 3006542627
- 3004043187
- 3003917514
- 3031915160
- 2030633
- 3016712364
- 2531491
- 3003741796
- 2432235
Source Documents#
Other 510(k) Records For Product Code CEN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091287 | VS-SENSE TEST | Common Sense , Ltd. | 2009-08-31 |
| K071100 | AMNISCREEN HOME DETECTION LINER KIT | Common Sense , Ltd. | 2007-10-15 |
| K051727 | AIMSTICK URINE REAGENT STRIPS | Germaine Laboratories, Inc. | 2005-10-26 |
| K030650 | STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS | Uridynamics, Inc. | 2003-04-14 |
| K962718 | FEMEXAM TESTCARD | Litmus Concepts, Inc. | 1997-02-07 |
| K840827 | KYOTEST 5V | Kyoto Diagnostics, Inc. | 1984-05-14 |
| K830824 | URINE SCREENING KIT | Syn-Kit, Inc. | 1983-06-12 |
| K830979 | HELENA BIOSTRIP PH | Helena Laboratories | 1983-05-05 |
| K830091 | LITH A TEST TM | Lenal Creative Approaches, Inc. | 1983-02-15 |
| K822241 | FOLATE/B12 DUO-BEAD RADIOASSAY | Abbott Laboratories | 1982-10-26 |
Legacy Summary#
summary
FDA Review#
Decision Summary