510(k) K862806
- Device
- Urine Diagnostic Reagent Strips
- Applicant
- AMATECH INTERNATIONAL, INC.
- 510(k) number
- K862806
- Product code
- JJB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-12-04
- Date received
- 1986-07-23
- Regulation
- 862.1115
- Classification name
- Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JERRY Y PARK
- Address
- 2400 Fountainview Suite 200 Houston TX US 77057 77057
FDA Registration Numbers#
- 9611444
- 3006198300
- 3005360469
- 9610633
- 3003795116
- 9710094
- 3038206980
- 1181121
- 4580
- 3004043187
- 9680746
- 3013545943
- 3007301207
- 3003741796
- 3013679502
- 3010324880
- 3031915160
- 2432235
- 3007126977
- 3015341499
- 1832216
- 2244821
- 1649661
- 8040374
- 3006621318
- 3009469260
- 3024463179
- 1550222
- 1036362
- 3030446844
- 3043127699
- 2517506
- 2122870
- 3021186226
- 1417592
- 3042471840
- 3002637618
- 1061932
- 1000119628
- 3004493545
- 9615507
- 3016712364
- 3008517993
- 1832816
- 3008987086
- 3009238284
- 3010891909
- 3024171133
- 3015972771
- 2531491
- 3003422726
- 3003917514
- 1616487
- 3008058135
- 9610126
- 2029372
- 3012494290
- 2030633
- 3012421607
- 3009448641
- 3023162659
- 1219029
- 3005841640
- 3004192065
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JJB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K943436 | URINE REAGENT STRIPS-8 PARAMETERS | Teco Diagnostics | 1995-04-24 |
| K943008 | BIOSCAN REAGENT STRIPS | Genesis Labs, Inc. | 1994-08-08 |
| K873553 | WAKO(TM) PRETEST 8A | Wako Chemicals USA, Inc. | 1987-09-22 |
| K833521 | REAGENT TESTS STRIP COMBINATIONS | Syn-Kit, Inc. | 1984-01-11 |