THE EXTRACTOR(TM)
FDA 510(k) clearance K873932 · decided 1987-11-20
Clearance details
- K-number
- K873932
- Device name
- THE EXTRACTOR(TM)
- Applicant
- Molecular Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-09-25
- Decision date
- 1987-11-20
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- DKO
- Device class
- 1
- Regulation number
- 862.2230
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED (P900059/S004) | Molecular Biosystems, Inc. | 1997-06-17 |
| ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES (P900059/S002) | Molecular Biosystems, Inc. | 1996-03-01 |
| ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES (P900059/S003) | Molecular Biosystems, Inc. | 1995-08-28 |
| ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES (P900059/S001) | Molecular Biosystems, Inc. | 1995-07-31 |