510(k) K921534
- Device
- DSL DHEA (DSL 8900)
- Applicant
- DIAGNOSTIC SYSTEMS LABORATORIES, INC.
- 510(k) number
- K921534
- Product code
- JKL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-05-26
- Date received
- 1992-03-31
- Regulation
- 862.1060
- Classification name
- Acid, Delta-aminolevulinic, Ion-exchange Columns With Colorimetry
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHNNY R WILLLIS
- Address
- 445 Medical Center Blvd. Webster TX US 77598 77598
FDA Registration Numbers#
- 3002706372
- 8043368
- 3021841051
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JKL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842310 | HEMATOLOGY ANALYZER | Hml Inc/Biotechnology Transfer | 1984-09-06 |
Legacy Summary#
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FDA Review#
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