510(k) K882766
- Device
- Emds Acetaminophen Calibrator No. 67636/95
- Applicant
- EM DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K882766
- Product code
- DLG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-08-23
- Date received
- 1988-07-06
- Regulation
- 862.2250
- Classification name
- Coating, Liquid, Glc
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BENTLEY, PHD
- Address
- 480 Democrat Rd. Gibbstown NJ US 08027 08027
FDA Registration Numbers#
- 2242547
Source Documents#
510(k) summary PDF not indicated by FDA
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| K894518 | FPR AMIKACIN CALIBRATOR KIT | Colony Laboratories, Inc. | 1989-09-28 |
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| K894528 | FPR PHENYTOIN CALIBRATOR KIT | Colony Laboratories, Inc. | 1989-09-25 |
| K833385 | N-ACETYLPROCAINAMIDE CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-16 |