Wako(Tm) Pretest 8A
FDA 510(k) K873553 · Wako Chemicals USA, Inc.
510(k) numberK873553
Submission
- Device name
- Wako(Tm) Pretest 8A
- Applicant
- Wako Chemicals USA, Inc.
Dallas, TX, US - Received
- August 28, 1987
- Decision date
- September 22, 1987
- 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 |
| K862806 | Urine Diagnostic Reagent StripsJJB · Traditional | Amatech International, Inc. | 12/04/1986SE |
| K833521 | Reagent Tests Strip CombinationsJJB · Traditional | Syn-Kit, Inc. | 01/11/1984SE |
More from Syn-Kit, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K100464 | Utaswako I30 (Includes Accessories), Utaswako AFP-L3, Calibrator Set, Control L, Control…NSF · Traditional | 02/23/2011SE |
| K080125 | Apolowako T-Cho, Hdl-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and…LBS · Traditional | 07/18/2008SE |
| K080123 | Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201CFR · Traditional | 07/17/2008SE |
| K061775 | Wako L-Type Creatinine-M Test, and Wako Creatinine CalibratorJFY · Traditional | 02/23/2007SE |
| K062368 | Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP…OAU · Traditional | 01/31/2007SE |
| K053132 | Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791JFM · Traditional | 12/30/2005SE |
| K053131 | Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191JFM · Traditional | 12/30/2005SE |
| K042551 | Multi-Chem Calibrator aJIX · Traditional | 11/16/2004SE |
| K042550 | Multi-Lipid CalibratorJIX · Traditional | 11/08/2004SE |
| K042549 | Multi Chem Cal BJIX · Traditional | 11/08/2004SE |
Questions and answers
When was Wako(Tm) Pretest 8A cleared by the FDA?
Wako(Tm) Pretest 8A (K873553) received a 510(k) decision of Substantially Equivalent on September 22, 1987, 25 days after the submission was received.
What is the product code of K873553?
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.