510(k) K883411
- Device
- PG-NUMERIC(TM)
- Applicant
- ISOLAB, INC.
- 510(k) number
- K883411
- Product code
- JHF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-03-15
- Date received
- 1988-08-15
- Regulation
- 862.1455
- Classification name
- Colorimetric Method, Lecithin/sphingomyelin Ratio
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WENDY S CLINE
- Address
- Drawer 4350 Akron OH US 44321 44321
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JHF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K940817 | TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II | Abbott Laboratories | 1995-02-08 |
Legacy Summary#
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FDA Review#
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