Gamma Fetal Bleed Screening Test
FDA 510(k) K820647 · Gamma Biologicals, Inc.
510(k) numberK820647
Submission
- Device name
- Gamma Fetal Bleed Screening Test
- Applicant
- Gamma Biologicals, Inc.
Walker, MI, US - Received
- March 9, 1982
- Decision date
- May 12, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIM – Test, Screening, For D Positive Fetal Rbc'S
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7455
- Specialty
- Hematology
Other 510(k)s with product code LIM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K980314 | Fetal D Tection KitLIM · Traditional | Biopool Intl., Inc. | 04/08/1998SE |
More from Biopool Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K864207 | Disposable Test Cards/Gamma Slide Test Infect MonoKTN · Traditional | 12/03/1986SE |
| K861016 | Gamma Slide Test for Infectious MononucleosisKTN · Traditional | 04/18/1986SE |
| K832473 | Gamma Slide Test for PregnancyJHJ · Traditional | 08/16/1983SE |
| K820072 | Fe-Cult PlusKHE · Traditional | 03/04/1982SE |
| K813342 | Gamma Chloroquine Diphosphate SolutionKSK · Traditional | 03/04/1982SE |
| K811752 | Fe-Cult PlusKHE · Traditional | 11/02/1981SE |
| K802534 | Gamma Pi Blood Group SubstanceKSX · Traditional | 11/12/1980SE |
| K802533 | Gamma Lewis Blood Group SubstanceKSX · Traditional | 11/12/1980SE |
| K800658 | Rst-Series ControlKSF · Traditional | 04/16/1980SE |
| K792583 | Gamma Arachis Hypogea LectinKSI · Traditional | 01/16/1980SE |
Questions and answers
When was Gamma Fetal Bleed Screening Test cleared by the FDA?
Gamma Fetal Bleed Screening Test (K820647) received a 510(k) decision of Substantially Equivalent on May 12, 1982, 64 days after the submission was received.
What is the product code of K820647?
The FDA product code is LIM – Test, Screening, For D Positive Fetal Rbc'S, a Class II (moderate risk) device regulated under 21 CFR 864.7455.