Amresco Liquizyme Glucose/Bun Standard 0124, 0200
FDA 510(k) K880654 · American Research Products Co.
510(k) numberK880654
Submission
- Device name
- Amresco Liquizyme Glucose/Bun Standard 0124, 0200
- Applicant
- American Research Products Co.
Solon, OH, US - Received
- February 17, 1988
- Decision date
- June 7, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIW – Calibrator, Surrogate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K970396 | Human Chorionic Gonadotropin CalibratorJIW · Traditional | Dade Chemistry Systems, Inc. | 02/20/1997SE |
| K910255 | Flow Cytometry Fitc/Pe Compensation KitJIW · Traditional | Sigma Diagnostics, Inc. | 04/03/1991SE |
| K902575 | Sopheia 1000 (S1CAL) & Sopheia 2000 (S2CAL)JIW · Traditional | Diagnostic Products Corp. | 10/04/1990SE |
| K902294 | Accuscan Microbead StandardsJIW · Traditional | Sigma Chemical Co. | 07/03/1990SE |
| K892213 | Acs Colloid Osmotic Pressure CalibratorJIW · Traditional | Analytical Control Systems, Inc. | 06/21/1989SE |
| K883389 | Raichem(Tm) Bilirubin Conjugate StandardJIW · Traditional | Reagents Applications, Inc. | 12/14/1988SE |
| K882220 | Calibration KitJIW · Traditional | King Diagnostics, Inc. | 08/02/1988SE |
| K880610 | Unimeter Calibration KitJIW · Traditional | Boehringer Mannheim Corp. | 03/24/1988SE |
| K854028 | Audit Automated Blood Chemistry AnalyzerJIW · Traditional | Verified Medical Research, Inc. | 12/02/1985SE |
More from Verified Medical Research, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942984 | Bun ReagentCDQ · Traditional | 03/01/1995SE |
| K901527 | Biuret (Colormetric), Total ProteinCEK · Traditional | 07/19/1990SE |
| K901964 | Phosphorus Reagents Prod Codes 7763/7764/7563/7463CEO · Traditional | 05/31/1990SE |
| K901960 | Iron Reagents Product Codes 7725 and 7726JMO · Traditional | 05/31/1990SE |
| K900827 | Colorimetric Chloride Product #4314125CHI · Traditional | 05/02/1990SE |
| K901702 | Nad Reduction, Alt/Spgt Codes 7722,7723,7422,7522CKA · Traditional | 04/25/1990SE |
| K900667 | Amresco Ldh-L Reagents Products #7710, 7711CFJ · Traditional | 04/19/1990SE |
| K900666 | Amresco Creatinine Reagents Product #7790, 7791CGX · Traditional | 04/19/1990SE |
| K900571 | Amresco Product Number 7728 (Bilirubin DPD)CIG · Traditional | 04/16/1990SE |
| K900977 | Amresco Inorganic Phosphorus Product #4312500CEO · Traditional | 04/11/1990SE |
Questions and answers
When was Amresco Liquizyme Glucose/Bun Standard 0124, 0200 cleared by the FDA?
Amresco Liquizyme Glucose/Bun Standard 0124, 0200 (K880654) received a 510(k) decision of Substantially Equivalent on June 7, 1988, 111 days after the submission was received.
What is the product code of K880654?
The FDA product code is JIW – Calibrator, Surrogate, a Class II (moderate risk) device regulated under 21 CFR 862.1150.