Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)
FDA 510(k) K951494 · Emd Chemicals, Inc.
510(k) numberK951494
Submission
- Device name
- Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)
- Applicant
- Emd Chemicals, Inc.
Gibbstown, NJ, US - Received
- March 31, 1995
- Decision date
- December 11, 1995
- 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
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|---|---|---|---|
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| 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 |
| 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 |
| K931141 | Biotrol Amylase CNPG3CIJ · Traditional | Biotrol, USA, Inc. | 05/26/1993SE |
| K882225 | -Amylase EpsCIJ · Traditional | Boehringer Mannheim Corp. | 01/03/1989SE |
| K873572 | Il 35260, Il Test Amylase ReagentCIJ · Traditional | Instrumentation Laboratory CO | 10/20/1987SE |
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| K951750 | Glucose Test Item Number 97375/94LFR · Traditional | 09/06/1995SE |
| K950234 | Total Protein Test (Tpro) Item Number: XXXXX/R1. R2CEK · Traditional | 06/14/1995SE |
| K950128 | Total Protein Test (Tpro) Item XXXXX/R1. R2CEK · Traditional | 05/15/1995SE |
| K945322 | Phosphorus Test (Phos) Item Number 65416CEO · Traditional | 12/07/1994SE |
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Questions and answers
When was Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR) cleared by the FDA?
Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR) (K951494) received a 510(k) decision of Substantially Equivalent on December 11, 1995, 255 days after the submission was received.
What is the product code of K951494?
The FDA product code is CIJ – Saccharogenic, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.