SR-PLUS DIRECT CHOLESTEROL TEST
FDA 510(k) clearance K780545 · decided 1978-05-26
Clearance details
- K-number
- K780545
- Device name
- SR-PLUS DIRECT CHOLESTEROL TEST
- Applicant
- Stanbio Laboratory
- Decision
- Substantially Equivalent
- Date received
- 1978-04-03
- Decision date
- 1978-05-26
- Days to decision
- 53 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
+ Add to Predicate Builder ◉ Watch Stanbio Laboratory
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 |
|---|---|---|
| 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 |
| CHOLESTEROL DET. IN SERUM (K781611) | Fisher Scientific Co., LLC | 1978-10-24 |
| 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.