Reagent Tests Strip Combinations
FDA 510(k) K833521 · Syn-Kit, Inc.
510(k) numberK833521
Submission
- Device name
- Reagent Tests Strip Combinations
- Applicant
- Syn-Kit, Inc.
Mchenry, IL, US - Received
- October 11, 1983
- Decision date
- January 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJB – Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1115
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K943436 | Urine Reagent STRIPS-8 ParametersJJB · Traditional | Teco Diagnostics | 04/24/1995SE |
| K943008 | Bioscan Reagent StripsJJB · Traditional | Genesis Labs, Inc. | 08/08/1994SE |
| K873553 | Wako(Tm) Pretest 8AJJB · Traditional | Wako Chemicals USA, Inc. | 09/22/1987SE |
| K862806 | Urine Diagnostic Reagent StripsJJB · Traditional | Amatech International, Inc. | 12/04/1986SE |
More from Amatech International, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861098 | Seroiden Strepto Kit 'Eiken'GTZ · Traditional | 08/12/1986SE |
| K861631 | Slide Culture U 'Eiken'JXA · Traditional | 06/10/1986SE |
| K854819 | CPR Slide EikenDCN · Traditional | 02/26/1986SE |
| K854820 | Ra 80 EikenDHR · Traditional | 01/17/1986SE |
| K853276 | Aso Slide EikenGTQ · Traditional | 08/20/1985SE |
| K843760 | Uropaper Eiken GJIL · Traditional | 12/18/1984SE |
| K843759 | Uropaper Eiken HagJIL · Traditional | 12/18/1984SE |
| K843758 | Uropaper Eiken GKJIL · Traditional | 12/18/1984SE |
| K843757 | Uropaper Eiken AGJIL · Traditional | 12/18/1984SE |
| K843756 | Uropaper Eiken 5JIL · Traditional | 12/18/1984SE |
Questions and answers
When was Reagent Tests Strip Combinations cleared by the FDA?
Reagent Tests Strip Combinations (K833521) received a 510(k) decision of Substantially Equivalent on January 11, 1984, 92 days after the submission was received.
What is the product code of K833521?
The FDA product code is JJB – Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1115.