Multichem Chloride Reagent S0933
FDA 510(k) K874812 · Simmler, Inc.
510(k) numberK874812
Submission
- Device name
- Multichem Chloride Reagent S0933
- Applicant
- Simmler, Inc.
St. Louis, MO, US - Received
- November 24, 1987
- Decision date
- December 18, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHJ – Mercuric Thiocyanate, Colorimetry, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010670 | Piccolo Chloride Test SystemCHJ · Traditional | Abaxis, Inc. | 04/26/2001SE |
| K945408 | 340-CHLORIDE for Discrete Random Access AnalyzerCHJ · Traditional | Catachem, Inc. | 02/22/1995SE |
| K943006 | Chloride QvetCHJ · Traditional | Prisma Systems | 12/07/1994SE |
| K934136 | Olympus Chloride Reagent, ModificationCHJ · Traditional | Olympus Corp. | 11/05/1993SE |
| K932528 | Olympus Chlorid Reagent, ModifiedCHJ · Traditional | Olympus Corp. | 09/17/1993SE |
| K925338 | Olympus Chloride ReagentCHJ · Traditional | Olympus Corp. | 12/11/1992SE |
| K922921 | King Diagnostics Chloride ReagentCHJ · Traditional | King Diagnostics, Inc. | 10/05/1992SE |
| K923610 | Olympus Chloride ReagentCHJ · Traditional | Olympus Corp. | 10/02/1992SE |
| K923036 | Urine ChlorideCHJ · Traditional | Heraeus Kulzer, Inc. | 09/09/1992SE |
| K911297 | Chloride ReagentCHJ · Traditional | Intersect Systems, Inc. | 04/16/1991SE |
More from Intersect Systems, 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 |
| 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 |
| K873697 | Multichem Calcium S0910CIC · Traditional | 10/02/1987SE |
Questions and answers
When was Multichem Chloride Reagent S0933 cleared by the FDA?
Multichem Chloride Reagent S0933 (K874812) received a 510(k) decision of Substantially Equivalent on December 18, 1987, 24 days after the submission was received.
What is the product code of K874812?
The FDA product code is CHJ – Mercuric Thiocyanate, Colorimetry, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.