SODIUM CITRATE
FDA 510(k) clearance K761177 · decided 1977-01-10
Clearance details
- K-number
- K761177
- Device name
- SODIUM CITRATE
- Applicant
- Bio/Data Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-12-01
- Decision date
- 1977-01-10
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- GJE
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| CUSTOMED BLOOD EXTRACTION KIT (K962596) | Customed, Inc. | 1996-09-27 |
| JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT (K925468) | J.J. Skinner, Inc. | 1994-04-11 |
| AUTO ISO-FILTER COLLECTION TUBE CAP (K780303) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-03-30 |
| RTERIAL BLOOD SAMPLING KIT (K771489) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-08-22 |
| ICROTAINEO BRAND TUBE (K771370) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-08-03 |
| TRAY, BLOOD SAMPLING (PULSATOR II) (K760086) | Concord Laboratories, Inc. | 1976-07-16 |
Recalls involving this device
No recalls on record reference this clearance.