Bnp-Amylase Test
FDA 510(k) K873133 · Sclavo, Inc.
510(k) numberK873133
Submission
- Device name
- Bnp-Amylase Test
- Applicant
- Sclavo, Inc.
Wayne, NJ, US - Received
- August 10, 1987
- Decision date
- October 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JFJ – Catalytic Methods, Amylase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1070
- Specialty
- Clinical Chemistry
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| K895943 | Normal and Abnormal Control SeraJJY · Traditional | 12/27/1989SE |
| K895822 | Total Bilirubin L.F.CIG · Traditional | 11/14/1989SE |
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| K880199 | Cholinesterase - Acetythiocholine SubstrateDIH · Traditional | 01/27/1989SE |
| K880049 | Cholinesterase - Butyrythiocholine SubstrateDIH · Traditional | 01/27/1989SE |
| K873496 | Atypical CholinesteraseDIH · Traditional | 01/27/1989SE |
| K884035 | Saitron 430 Random Access Chemistry AnalyzerJJE · Traditional | 12/29/1988SE |
Questions and answers
When was Bnp-Amylase Test cleared by the FDA?
Bnp-Amylase Test (K873133) received a 510(k) decision of Substantially Equivalent on October 6, 1987, 57 days after the submission was received.
What is the product code of K873133?
The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.