ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
FDA premarket approval P900059/S001 · decided 1995-07-31
Approval details
- PMA number
- P900059
- Supplement
- S001
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
- Generic name
- Contrast media, ultrasound
- Applicant
- Molecular Biosystems, Inc.
- Date received
- 1994-09-12
- Decision date
- 1995-07-31
- Days to decision
- 322 days
- Decision code
- APPR
- Product code
- MJS
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR 2 TRAINING VIDOES.FDA HAS RECEIVED A JOURNAL ADVERTISING INSERT, PRODUCT FOLDER, & 2 JOURNAL ARTICLES & FIND THAT THEY ARE CONSISTENT WITH APPROVED LABELING.EXPIRATION DATING 12 MONTHS REFRIGERATED AT 2 TO 8 DEGREES CELSIUS
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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 |