510(k) BK850024
- Device
- Potentiating Media For In Vitro Diagnostic Use
- Applicant
- Gamma Biologicals, Inc.
- 510(k) number
- BK850024
- Product code
- KSG
- Decision
- Substantially Equivalent (SE)
- Decision date
- 1986-03-20
- Date received
- 1986-01-15
- Regulation
- 864.9600
- Classification name
- Media, Potentiating For In Vitro Diagnostic Use
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Other 510(k) Records For Product Code KSG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K812565 | ELUTION SOLUTION | Biological Corp. of America | 1981-10-23 |
| K812222 | EM-X | Biological Corp. of America | 1981-09-23 |
| K800943 | PENTEX BOVINE ALBUMIN 30% SOLUTION | Miles Laboratories, Inc. | 1980-05-08 |
| K800189 | BOVINE ALBUMIN 22% & 30% SOLUTIONS | Gotham Biologics, Inc. | 1980-02-13 |
| K791791 | ORTHO ANTIBODY ENHANCEMENT SOLUTION | Ortho Diagnostics, Inc. | 1979-10-11 |
| K791113 | LOW IONIC STRENGTH SOLUTION (LISS) | Hyland Therapeutic Div., Travenol Laboratories | 1979-06-28 |
| K790973 | LO-ION | Gamma Biologicals, Inc. | 1979-06-15 |
| K790776 | DADE LOW IONIC STRENGTH SOLUITION (LISS) | Dade, Baxter Travenol Diagnostics, Inc. | 1979-05-23 |
| K790498 | LISS REAGENT | Fisher Scientific Co., LLC | 1979-04-03 |
| K781397 | EM-V | Biological Corp. of America | 1978-09-14 |
| K781435 | ORTHO LOW IONIC SOLUTION | Ortho Diagnostics, Inc. | 1978-09-14 |
| K780413 | LOW IIONIC STRENGTH SOLUTION | Pfizer, Inc. | 1978-04-24 |
| K780556 | SPECT RIM (LISS) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-04-24 |
Legacy Summary#
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FDA Review#
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