510(k) K854016
- Device
- ASSERACHROM PROTEIN C KIT
- Applicant
- AMERICAN BIOPRODUCTS CO.
- 510(k) number
- K854016
- Product code
- JLA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-01-03
- Date received
- 1985-09-27
- Regulation
- 862.1210
- Classification name
- Conversion To Creatinine, Creatine
- Medical specialty
- Clinical Chemistry
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- B LE
- Address
- 601 N. Jefferson Rd. Parsippany NJ US 07054 07054
FDA Registration Numbers#
- 3008987086
- 3038206980
- 3021010433
- 3007301207
- 3043127699
- 9710666
- 2245451
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JLA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K852767 | ERYTHOCYTE CREATINE | Panmed, Inc. | 1986-11-13 |
Legacy Summary#
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FDA Review#
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