510(k) K882719
- Device
- Easy-test Emit Acetaminophen (actm) No. 16653
- Applicant
- EM DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K882719
- Product code
- LDP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-08-08
- Date received
- 1988-07-01
- Regulation
- 862.3030
- Classification name
- Colorimetry, Acetaminophen
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BENTLEY, PHD
- Address
- 480 Democrat Rd. Gibbstown NJ US 08027 08027
FDA Registration Numbers#
- 8020316
- 3006198300
- 3005360469
- 3003795116
- 2050012
- 3005333358
- 2432235
- 9610529
- 1319809
- 3012963943
- 2250051
- 3010939897
- 2517506
- 3002642396
- 3017101757
- 2050010
- 3010825766
- 1616487
- 9610126
- 1319681
- 3000308930
Source Documents#
510(k) summary PDF not indicated by FDA
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| K002974 | EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL | Dade Behring, Inc. | 2000-10-11 |
| K000494 | SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT | Beckman Coulter, Inc. | 2000-04-14 |
| K991598 | COBAS INTEGRA ACETAMINOPHEN | Roche Diagnostics Corp. | 1999-07-22 |
| K981059 | ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. | Diagnostic Chemicals , Ltd. | 1998-05-12 |