SGPT Reagent Set
FDA 510(k) K821207 · Omega Medical Electronics
510(k) numberK821207
Submission
- Device name
- SGPT Reagent Set
- Applicant
- Omega Medical Electronics
Mchenry, IL, US - Received
- April 27, 1982
- Decision date
- July 14, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CKD – Hydrazone Colorimetry, Alt/Sgpt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1030
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CKD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991834 | Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772CKD · Traditional | Cholestech Corp. | 09/09/1999SE |
| K941192 | Ortho Alt Microwell Test SystemCKD · Traditional | Ortho Diagnostic Systems, Inc. | 05/16/1995SE |
| K896237 | Cobas Ready Alt ReagentCKD · Traditional | Roche Diagnostic Systems, Inc. | 02/16/1990SE |
| K884784 | Virgo(R) Microwell Alt AssayCKD · Traditional | Electro-Nucleonics, Inc. | 12/29/1988SE |
| K883387 | Alanine Amino Transferase (Colorimetric Method)CKD · Traditional | Tech-Co, Inc. | 10/13/1988SE |
| K864082 | Reflotron(R) Alt (GPT)CKD · Traditional | Boehringer Mannheim Corp. | 12/04/1986SE |
| K860485 | SGPT (Alt) Reagent Set (Colorimetric)CKD · Traditional | Sterling Diagnostics, Inc. | 04/03/1986SE |
| K844283 | SGPT Reagent SetCKD · Traditional | Livonia Diagnostics, Inc. | 11/27/1984SE |
| K841059 | SGPT Reagent SetCKD · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K820491 | SGPT Reagent SetCKD · Traditional | Anco Medical Reagents & Assoc. | 03/11/1982SE |
More from Anco Medical Reagents & Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K823691 | Phosphorus Reagent SetCEO · Traditional | 01/07/1983SE |
| K821212 | Urea Nitrogen Reagent SetCDW · Traditional | 07/22/1982SE |
| K821206 | Sgpt-Uv Reagent SetCKA · Traditional | 07/22/1982SE |
| K821204 | Glucose(Enzymatic) Reagent SetCGA · Traditional | 07/22/1982SE |
| K821208 | Sgot-Uv Reagent SetCIT · Traditional | 07/20/1982SE |
| K821205 | Triglyceride Reagent SetCDT · Traditional | 07/20/1982SE |
| K821201 | Ldh-Uv Reagent SetCFJ · Traditional | 07/20/1982SE |
| K821209 | Sgot Reagent SetCIQ · Traditional | 07/14/1982SE |
| K821213 | Uric Acid Reagent SetCDH · Traditional | 07/13/1982SE |
| K821210 | Serum Total Protein Reagent SetCEK · Traditional | 07/13/1982SE |
Questions and answers
When was SGPT Reagent Set cleared by the FDA?
SGPT Reagent Set (K821207) received a 510(k) decision of Substantially Equivalent on July 14, 1982, 78 days after the submission was received.
What is the product code of K821207?
The FDA product code is CKD – Hydrazone Colorimetry, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.