510(k) K882038
- Device
- GDS ENZYMATIC SALICYLATE REAGENT
- Applicant
- GDS TECHNOLOGY, LLC.
- 510(k) number
- K882038
- Product code
- DKJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-06-24
- Date received
- 1988-05-16
- Regulation
- 862.3830
- Classification name
- Colorimetry, Salicylate
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DE CASTRO
- Address
- 25235 Leer Dr. P.O. Box 473 Elkhart IN US 46515 46515
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 #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093939 | ADVIA CHEMISTRY SALICYLATE REAGENT | Siemens Healthcare Diagnostics | 2010-05-19 |
| K042329 | SALICYLATE-SL ASSAY | Diagnostic Chemicals , Ltd. | 2004-12-27 |
| K020794 | SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-07-11 |
| K014173 | SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR | Beckman Coulter, Inc. | 2002-02-15 |
| K011878 | EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL | Syva Co. | 2001-08-13 |
| 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 |
| K873425 | EASY-TEST SALICYLATE (SAL) #16691 | Em Diagnostic Systems, Inc. | 1987-10-29 |
| K872321 | EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93 | Em Diagnostic Systems, Inc. | 1987-08-28 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases