510(k) K820647
- Device
- GAMMA FETAL BLEED SCREENING TEST
- Applicant
- GAMMA BIOLOGICALS, INC.
- 510(k) number
- K820647
- Product code
- LIM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-05-12
- Date received
- 1982-03-09
- 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
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
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 |
|---|---|---|---|
| K980314 | FETAL D TECTION KIT | Biopool Intl., Inc. | 1998-04-08 |
Legacy Summary#
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FDA Review#
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