Emds Salicylate (Sal) Calibrator, No# 67641/93
FDA 510(k) K872321 · Em Diagnostic Systems, Inc.
510(k) numberK872321
Submission
- Device name
- Emds Salicylate (Sal) Calibrator, No# 67641/93
- Applicant
- Em Diagnostic Systems, Inc.
Gibbstown, NJ, US - Received
- June 17, 1987
- Decision date
- August 28, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DKJ – Colorimetry, Salicylate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3830
- Specialty
- Clinical Toxicology
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| K014173 | Synchron Systems Salicylate Reagent and CalibratorDKJ · Traditional | Beckman Coulter, Inc. | 02/15/2002SE |
| K011878 | Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators…DKJ · Traditional | Syva Co. | 08/13/2001SE |
| K981872 | Salicylate-Sl Assay Catalogue Number 511-20,511-40DKJ · Traditional | Diagnostic Chemicals , Ltd. | 06/29/1998SE |
| K980032 | Salicylate Assay (Ace), Catalogue Number 501-71DKJ · Traditional | Diagnostic Chemicals , Ltd. | 03/02/1998SE |
| K964715 | Paramax Salicylate ReagentDKJ · Traditional | Dade Intl., Inc. | 04/25/1997SE |
| K961131 | Salicylate AssayDKJ · Traditional | Diagnostic Reagents, Inc. | 04/29/1996SE |
| K951290 | Axsym SalicylateDKJ · Traditional | Abbott Laboratories | 08/08/1995SE |
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Questions and answers
When was Emds Salicylate (Sal) Calibrator, No# 67641/93 cleared by the FDA?
Emds Salicylate (Sal) Calibrator, No# 67641/93 (K872321) received a 510(k) decision of Substantially Equivalent on August 28, 1987, 72 days after the submission was received.
What is the product code of K872321?
The FDA product code is DKJ – Colorimetry, Salicylate, a Class II (moderate risk) device regulated under 21 CFR 862.3830.