510(k) K980314
- Device
- FETAL D TECTION KIT
- Applicant
- BIOPOOL INTL., INC.
- 510(k) number
- K980314
- Product code
- LIM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-04-08
- Date received
- 1998-01-27
- Regulation
- 864.7455
- Classification name
- Test, Screening, For D Positive Fetal Rbc's
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER L MINETTI
- Address
- 1230 Wilson Dr. West Chester PA US 19380 19380
FDA Registration Numbers#
- 2029372
- 1034569
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LIM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K820647 | GAMMA FETAL BLEED SCREENING TEST | Gamma Biologicals, Inc. | 1982-05-12 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases