CHOLESTEROL DET. IN SERUM
FDA 510(k) clearance K781611 · decided 1978-10-24
Clearance details
- K-number
- K781611
- Device name
- CHOLESTEROL DET. IN SERUM
- Applicant
- Fisher Scientific Co., LLC
- Decision
- Substantially Equivalent
- Date received
- 1978-09-19
- Decision date
- 1978-10-24
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- CGO
- Device class
- 1
- Regulation number
- 862.1175
- 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 |
|---|---|---|
| CHOLESTEROL (K850938) | Dilab, Inc. | 1985-06-25 |
| KING DIAGNOSTICS CHOLESTEROL TEST (K811747) | King Diagnostics, Inc. | 1981-07-10 |
| CHOLESTEROL REAGENT (K810090) | Anco Medical Reagents & Assoc. | 1981-01-26 |
| REAGENTS FOR DETERM. CHOLESTEROL/SERUM (K800682) | Diagnostic Solutions, Inc. | 1980-05-28 |
| SR-PLUS DIRECT CHOLESTEROL TEST (K780545) | Stanbio Laboratory | 1978-05-26 |
| ALPHA/CHOL (K772043) | Standard Scientific, Inc. | 1977-11-28 |
| CHOLESTEROL (K771833) | Gamma Enterprises, Inc. | 1977-10-18 |
| CHOLESTEROL REAGENT (K771313) | Mallinckrodt Critical Care | 1977-08-03 |
| UNIPAK CHOLESTEROL (K771093) | Harleco | 1977-07-21 |
| CHOLESTEROL PROCEDURE, TEKPOINT TOTAL (K770457) | Icn Pharmaceuticals, Inc. | 1977-05-03 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| FLUORESCENT GONORRHEA TEST-HEATED (FGT-H) (P770001) | Fisher Scientific Co., LLC | 1979-07-18 |