Cholesterol Standards
FDA 510(k) K770277 · Worthington Biochemical Corp.
510(k) numberK770277
Submission
- Device name
- Cholesterol Standards
- Applicant
- Worthington Biochemical Corp.
Mchenry, IL, US - Received
- February 14, 1977
- Decision date
- March 1, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K171168 | VITROS Immunodiagnostic Products Insulin CalibratorsJIT · Abbreviated | Ortho Clinical Diagnostics | 05/16/2017SE |
| K170938 | CalSet IGF-1JIT · Traditional | Roche Diagnostics | 04/26/2017SE |
| K170160 | Abbott ARCHITECT Free T3JIT · Traditional | Abbott Laboratories | 02/15/2017SE |
| K163546 | Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163534 | Lumipulse G FSH-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163544 | Lumipulse G ProlactinJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163521 | Lumipulse G LH CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163078 | Dc-Uibc-CalJIT · Abbreviated | Sekisui Diagnostics P.E.I., Inc. | 12/08/2016SE |
| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 12/01/2016SE |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorJIT · Special | Siemens Healthcare Diagnostics | 11/17/2016SE |
More from Siemens Healthcare Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K780389 | HDL Reagent Set for LipoproteinsCHH · Traditional | 04/19/1978SE |
| K780096 | LDH Isoenzyme Control SerumJJY · Traditional | 03/03/1978SE |
| K772356 | LDH Isoenzyme Column Reagent SetCEX · Traditional | 01/24/1978SE |
| K772025 | Uric Acid Std. for Quant. Uric AcidJIS · Traditional | 11/11/1977SE |
| K771143 | Inorganic Phosphorus StandardsJIT · Traditional | 07/11/1977SE |
| K771001 | Statzyme GlucoseCGA · Traditional | 07/11/1977SE |
| K770831 | Statzyme Uric Acid ReagentCDO · Traditional | 07/11/1977SE |
| K770470 | Worthington BunCDW · Traditional | 06/02/1977SE |
| K761263 | Cholesterol Automated ReagentCHH · Traditional | 12/29/1976SE |
| K761262 | Triglycerides (Lipase) Reagent SetCDT · Traditional | 12/29/1976SE |
Questions and answers
When was Cholesterol Standards cleared by the FDA?
Cholesterol Standards (K770277) received a 510(k) decision of Substantially Equivalent on March 1, 1977, 15 days after the submission was received.
What is the product code of K770277?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.