Emds N-Acetylprocainamide Calibrator #67635/95
FDA 510(k) K874101 · Em Diagnostic Systems, Inc.
510(k) numberK874101
Submission
- Device name
- Emds N-Acetylprocainamide Calibrator #67635/95
- Applicant
- Em Diagnostic Systems, Inc.
Gibbstown, NJ, US - Received
- October 8, 1987
- Decision date
- November 9, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DLJ – Calibrators, Drug Specific
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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| 510(k) | Device | Decision |
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| K935181 | Aspartate Aminotransferase (Ast) TestCIT · Traditional | 01/27/1994SE |
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| K935179 | Emds Albumin (Alb) TestCIX · Traditional | 12/17/1993SE |
| K935178 | Emds Phosphorous (Phos) TestCEO · Traditional | 12/17/1993SE |
| K935177 | Gamma-Glutamyl Transferase (GGT) TestJQB · Traditional | 12/16/1993SE |
| K935176 | Iron TestJIY · Traditional | 12/16/1993SE |
| K935175 | Lactate Dehydrogenase (LD)CFJ · Traditional | 12/16/1993SE |
| K935174 | Total Protein Test (Tpro)CEK · Traditional | 12/16/1993SE |
| K935136 | Cholesterol (Chol) Test Item No. 65410CHH · Traditional | 12/16/1993SE |
| K935183 | Emds Magnesium (MG) TestJGJ · Traditional | 12/09/1993SE |
Questions and answers
When was Emds N-Acetylprocainamide Calibrator #67635/95 cleared by the FDA?
Emds N-Acetylprocainamide Calibrator #67635/95 (K874101) received a 510(k) decision of Substantially Equivalent on November 9, 1987, 32 days after the submission was received.
What is the product code of K874101?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.