HANKS' BALANCED SALTS SOLUTION (MODIF.)
FDA 510(k) clearance K810777 · decided 1981-05-08
Clearance details
- K-number
- K810777
- Device name
- HANKS' BALANCED SALTS SOLUTION (MODIF.)
- Applicant
- Dutchland Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-03-23
- Decision date
- 1981-05-08
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- KIP
- Device class
- 1
- Regulation number
- 864.2875
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |
|---|---|---|
| (D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030 (K870482) | Sigma Chemical Co. | 1987-03-30 |
| KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002 (K870491) | Sigma Chemical Co. | 1987-03-30 |
| EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 (K870486) | Sigma Chemical Co. | 1987-03-30 |
| HANKS' BALANCED SALTS (HBSS) NO. H1387 (K870484) | Sigma Chemical Co. | 1987-03-30 |
| DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 (K860784) | Tissue Culture Innovations | 1986-03-12 |
| HEPES BUFFER IM IN NORMAL SALINE (K844877) | Hazleton Research Products, Inc. | 1985-02-25 |
| TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG (K844878) | Hazleton Research Products, Inc. | 1985-02-25 |
| SALINE, 1.3% W/O PRESERVATIVE (K842723) | E K Ind., Inc. | 1984-08-03 |
| SALINE, 0.85%W/PRESERVATIVE (K842725) | E K Ind., Inc. | 1984-08-03 |
| SALINE 0.85% W/O PRESERVATIVE (K842724) | E K Ind., Inc. | 1984-08-03 |
| EBS POWDER (K820928) | Dutchland Laboratories, Inc. | 1982-04-21 |
| DULBECCO'S PBS POWDER (K820923) | Dutchland Laboratories, Inc. | 1982-04-21 |
Recalls involving this device
No recalls on record reference this clearance.