510(k) K872321
- Device
- Emds Salicylate (sal) Calibrator, No# 67641/93
- Applicant
- EM DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K872321
- Product code
- DKJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-08-28
- Date received
- 1987-06-17
- Regulation
- 862.3830
- Classification name
- Colorimetry, Salicylate
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAYMOND L MILLER
- Address
- 480 Democrat Rd. Gibbstown NJ US 08027 08027
FDA Registration Numbers#
- 8020316
- 3006198300
- 3003795116
- 2050012
- 3005333358
- 2432235
- 9610529
- 1319809
- 3012963943
- 2250051
- 2517506
- 3002642396
- 3017101757
- 2050010
- 3010825766
- 1616487
- 9610126
- 1319681
- 3000308930
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DKJ#
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|---|---|---|---|
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| K014173 | SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR | Beckman Coulter, Inc. | 2002-02-15 |
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| K981872 | SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 | Diagnostic Chemicals , Ltd. | 1998-06-29 |
| K980032 | SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 | Diagnostic Chemicals , Ltd. | 1998-03-02 |
| K964715 | PARAMAX SALICYLATE REAGENT | Dade Intl., Inc. | 1997-04-25 |
| K961131 | SALICYLATE ASSAY | Diagnostic Reagents, Inc. | 1996-04-29 |
| K951290 | AXSYM SALICYLATE | Abbott Laboratories | 1995-08-08 |
| K946000 | ABUSCREEN ONLINE(R) CALIBRATORS | Roche Diagnostic Systems, Inc. | 1995-01-25 |
| K904301 | DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1990-11-09 |
| K902356 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI) | Eastman Kodak Company | 1990-07-16 |
| K882038 | GDS ENZYMATIC SALICYLATE REAGENT | Gds Technology, LLC | 1988-06-24 |
| K873425 | EASY-TEST SALICYLATE (SAL) #16691 | Em Diagnostic Systems, Inc. | 1987-10-29 |