Biotrol Amylase CNPG3
FDA 510(k) K931141 · Biotrol, USA, Inc.
510(k) numberK931141
Submission
- Device name
- Biotrol Amylase CNPG3
- Applicant
- Biotrol, USA, Inc.
Exton, PA, US - Received
- March 5, 1993
- Decision date
- May 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CIJ – Saccharogenic, Amylase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1070
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023396 | Amylase EPS-G7 (Liquid) Reagent Set, (Hitachi Analyzers)CIJ · Traditional | Pointe Scientific, Inc., | 12/23/2002SE |
| K991817 | Additional Ims Assays for the Bayer Advia Ims SystemCIJ · Traditional | Bayer Corp. | 07/22/1999SE |
| K980013 | AmylaseCIJ · Traditional | Ac Biochemicals, Inc. | 02/04/1998SE |
| K953211 | Amylase (Ethylidene PNGPG7) KitCIJ · Traditional | Randox Laboratories, Ltd. | 06/21/1996SE |
| K951494 | Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)CIJ · Traditional | Emd Chemicals, Inc. | 12/11/1995SE |
| K940735 | Liquid Amylase (CNPG3) Reagent SetCIJ · Traditional | Pointe Scientific, Inc., | 08/01/1994SE |
| K940010 | Dma Amylase (Demand) ProcedureCIJ · Traditional | Data Medical Associates, Inc. | 03/11/1994SE |
| K931301 | Olympus Amylase ReagentCIJ · Traditional | Olympus Corp. | 10/18/1993SE |
| K882225 | -Amylase EpsCIJ · Traditional | Boehringer Mannheim Corp. | 01/03/1989SE |
| K873572 | Il 35260, Il Test Amylase ReagentCIJ · Traditional | Instrumentation Laboratory CO | 10/20/1987SE |
More from Instrumentation Laboratory CO
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| K921855 | Biotrol Bicarbonate StandardsJIS · Traditional | 08/03/1992SE |
| K921677 | Biotrol Magnesium (Magon)JGJ · Traditional | 05/26/1992SE |
| K912795 | Biotrol Uibc ReagentJMO · Traditional | 08/12/1991SE |
| K910721 | Biotrol Protein Multilevel StandardsJIS · Traditional | 05/06/1991SE |
| K905683 | Biotrol Lactate Dehydrogenase (L-P)CFJ · Traditional | 03/11/1991SE |
| K905280 | Biotrol Bilirubin C & T ControlJJX · Traditional | 02/04/1991SE |
| K894544 | Biotrol Rub-E.I.A. Test GLFX · Traditional | 08/30/1989SE |
| K891061 | Biotrol Calcium MonoreactifCJY · Traditional | 08/10/1989SE |
| K891286 | Biotrol Chemistry Urine ControlJJW · Traditional | 04/10/1989SE |
Questions and answers
When was Biotrol Amylase CNPG3 cleared by the FDA?
Biotrol Amylase CNPG3 (K931141) received a 510(k) decision of Substantially Equivalent on May 26, 1993, 82 days after the submission was received.
What is the product code of K931141?
The FDA product code is CIJ – Saccharogenic, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.