Multichem Calcium S0910
FDA 510(k) K873697 · Simmler, Inc.
510(k) numberK873697
Submission
- Device name
- Multichem Calcium S0910
- Applicant
- Simmler, Inc.
St. Louis, MO, US - Received
- September 14, 1987
- Decision date
- October 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIC – Cresolphthalein Complexone, Calcium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1145
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130870 | Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (Ca)CIC · Traditional | Hitachi Chemical Diagnostics, Inc. | 05/02/2013SE |
| K083339 | Dimension RXL Max with Advia Modular Automation System (Amas)CIC · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/09/2009SE |
| K070249 | Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HCIC · Traditional | Horiba Abx | 04/26/2007SE |
| K053401 | Spotchem II Chemistry Basic 1 and Chemistry Basic 2 TestsCIC · Traditional | Arkray, Inc. | 03/24/2006SE |
| K050077 | Spotchem II Calcium, Magnesium, and Blood Urea Nitrogen TestsCIC · Traditional | Arkray, Inc. | 02/15/2005SE |
| K041009 | Raichem Calcium (Ocpc) Liquid ReagentCIC · Traditional | Hemagen Diagnostics, Inc. | 06/25/2004SE |
| K023105 | Atac Calcium Reagent and Atac CalibratorCIC · Traditional | Elan Diagnostics | 03/13/2003SE |
| K013652 | Wiener Lab. Ca-Color Aa, Model 4 X 50 ML Cat.N 1152002CIC · Traditional | Wiener Laboratories Saic | 12/21/2001SE |
| K000375 | Randox CalciumCIC · Traditional | Randox Laboratories, Ltd. | 04/05/2000SE |
| K991111 | Buffer Chromogen (R1), Product No. CA110-01, Edta Reagen (R2), Product No. CA110-02CIC · Traditional | A.P. Total Care, Inc. | 05/25/1999SE |
More from A.P. Total Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K895745 | Sickle Cell Solubility Test KitJBB · Traditional | 11/29/1989SE |
| K874903 | Multichem(R) Y -Glutamyltransferase (Y -Gt)JPZ · Traditional | 02/11/1988SE |
| K874595 | Multichem (R) Magnesium ReagentJGJ · Traditional | 01/21/1988SE |
| K874820 | Multichem HDL Precipitating Reagent #S0914LBR · Traditional | 01/07/1988SE |
| K874812 | Multichem Chloride Reagent S0933CHJ · Traditional | 12/18/1987SE |
| K874311 | Multichem (R) Total BilirubinCIG · Traditional | 11/25/1987SE |
| K874049 | Multichem Albumin Reagent S0902CIX · Traditional | 10/29/1987SE |
| K874038 | Multichem Inorganic Phosphorous S0923CEO · Traditional | 10/28/1987SE |
| K873725 | Multichem Creatinine Reagent S0917CGX · Traditional | 10/20/1987SE |
| K873761 | Multichem Alkaline Phosphatase (S0903)CJE · Traditional | 10/07/1987SE |
Questions and answers
When was Multichem Calcium S0910 cleared by the FDA?
Multichem Calcium S0910 (K873697) received a 510(k) decision of Substantially Equivalent on October 2, 1987, 18 days after the submission was received.
What is the product code of K873697?
The FDA product code is CIC – Cresolphthalein Complexone, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.