MONOJET SAMPLETTE ADAPTERS
FDA 510(k) clearance K832578 · decided 1983-08-31
Clearance details
- K-number
- K832578
- Device name
- MONOJET SAMPLETTE ADAPTERS
- Applicant
- Sherwood Medical Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-02
- Decision date
- 1983-08-31
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- GIO
- Device class
- 1
- Regulation number
- 864.6150
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sherwood Medical Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM (K972969) | Innovative Medical Technologies, Inc. | 1997-09-22 |
| MONOJECT SAMPLETTE SEPARATOR TUBE (K941291) | Sherwood Medical Co. | 1994-10-27 |
| TRU-TRAX (K894851) | Humagen, Inc. | 1989-09-29 |
| HEMA(PRO)TEC(TION) (K885324) | Medical Products Search, Inc. | 1989-02-17 |
| CAPILLARY TUBE, BLOOD COLLECTION (K885138) | Coeur Laboratories, Inc. | 1989-02-07 |
| SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE (K884623) | Safe-Tec Clinical Products, Inc. | 1988-12-01 |
| NATELSON TUBES, HEPARIN AND PLAIN (K881187) | Helps Products, Inc. | 1988-05-06 |
| CARAWAY TUBES, HEPARIN AND PLAIN (K881262) | Helps Products, Inc. | 1988-05-06 |
| MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR (K875061) | Sherwood Medical Co. | 1988-01-12 |
| VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE (K873647) | Ventrex Laboratories, Inc. | 1987-10-20 |
| CORNING BLOOD COLLECTION CAPILLARY TUBES (K850806) | Corning Medical & Scientific | 1985-03-25 |
| CAPILLARY BLOOD COLLECTION TUBE (K843608) | Medical Technomics, Ltd. | 1984-11-30 |
Recalls involving this device
No recalls on record reference this clearance.