IMMUNOHEMATOLOGICAL SALINE #97139
FDA 510(k) clearance K831200 · decided 1983-05-09
Clearance details
- K-number
- K831200
- Device name
- IMMUNOHEMATOLOGICAL SALINE #97139
- Applicant
- Emd Chemicals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-11
- Decision date
- 1983-05-09
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- JCE
- 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 |
|---|---|---|
| BUFFERED SALINE (K842722) | E K Ind., Inc. | 1984-09-11 |
| CERTIFIED BLOOD BANK SALINE (K801506) | Nobel Scientific Industries, Inc. | 1980-07-28 |
| COUITER/CMS ISOTONIC BLOOD BANK SALINE (K792101) | Coulter Electronics, Inc. | 1979-11-20 |
| LYSING AGENT AF (K761183) | Central Labs. Assoc. MD Pathologists | 1977-01-17 |
| PHYSIOLOGIC SALINE (0.85%) (K761174) | Bio/Data Corp. | 1977-01-10 |
| BARBITAL SALINE BUFFER (K761170) | Bio/Data Corp. | 1977-01-10 |
Recalls involving this device
No recalls on record reference this clearance.