MILLONIGS MODIFIED PHOSPHATE BUFFERED
FDA 510(k) clearance K830514 · decided 1983-03-08
Clearance details
- K-number
- K830514
- Device name
- MILLONIGS MODIFIED PHOSPHATE BUFFERED
- Applicant
- Surgipath Medical Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-17
- Decision date
- 1983-03-08
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- IFP
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CONSED FECAL CONCENTRATION SYSTEM (K884755) | Donald L. Price, Ph.D. | 1989-01-10 |
| DRY-FORM (K872663) | Anatech, Ltd. | 1987-08-06 |
| (MSI) PATH-SAVER (K872140) | Medical Specialties, Inc. | 1987-06-15 |
| NBF 10% NEUTRAL BUFFERED FORMALIN (K870852) | Anatech, Ltd. | 1987-03-31 |
| PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN (K853497) | Surgipath Medical Industries, Inc. | 1985-08-28 |
| FORMALIN BUFFERED (K842982) | Reagent Laboratory, Inc. | 1984-10-01 |
| CBA FORMALIN (K842940) | Anatech, Ltd. | 1984-08-28 |
| BUF-FIX (K842728) | E K Ind., Inc. | 1984-08-03 |
| FORMALIN SOLUTION 10% NEUTRAL BUFFER (K840926) | Sigma Chemical Co. | 1984-03-12 |
| MILLONIG'S MODIFIED PHOSPHATE BUFFERED (K830582) | Surgipath Medical Industries, Inc. | 1983-03-17 |
| NEUTRAL BUFFERED FORMALIN 10% (K830583) | Surgipath Medical Industries, Inc. | 1983-03-17 |
| 10% NEUTRAL BUFFERED FORMALIN CONCENT (K812940) | Surgipath | 1981-12-10 |
Recalls involving this device
No recalls on record reference this clearance.