ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
FDA premarket approval P900059/S003 · decided 1995-08-28
Approval details
- PMA number
- P900059
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
- Generic name
- Contrast media, ultrasound
- Applicant
- Molecular Biosystems, Inc.
- Date received
- 1995-06-05
- Decision date
- 1995-08-28
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- MJS
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR RELEASE OF FINAL PRODUCT BASED ON RESULTS FROM KINETIC QUANTITATIVE CHROMOGENIC LAL BATERIAL ENDOTOXIN TEST AND REPLACEMENT OF TAII COULTER COUNTER WITH MULTISIZER IIE COULTER COUNTER FOR PARTICLE SIZE MEASUREMENT
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT (K874544) | Molecular Biosystems, Inc. | 1988-08-12 |
| SNAP CAMPYLOBACTOR DIAGNOSTIC KIT (K873670) | Molecular Biosystems, Inc. | 1988-06-08 |
| SNAP(R) ROTAVIRUS DIAGNOSTIC KIT (K873565) | Molecular Biosystems, Inc. | 1988-05-13 |
| THE EXTRACTOR(TM) (K873932) | Molecular Biosystems, Inc. | 1987-11-20 |