Chloride Color & Chloride Sample Diluent
FDA 510(k) K802163 · Panmed, Inc.
510(k) numberK802163
Submission
- Device name
- Chloride Color & Chloride Sample Diluent
- Applicant
- Panmed, Inc.
Mchenry, IL, US - Received
- September 8, 1980
- Decision date
- October 10, 1980
- 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 |
|---|---|---|
| K852767 | Erythocyte CreatineJLA · Traditional | 11/13/1986SE |
| K820642 | Sickle-CheckGHM · Traditional | 04/14/1982SE |
| K802164 | 8-HYDROXYQUINOLINE, Cresolphthalein Com.CIC · Traditional | 10/10/1980SE |
| K802162 | CO2 Color Reagent & CO2 Sample DiluentKMS · Traditional | 10/10/1980SE |
| K802161 | Biuret Reagent & Total Protein Blank SolCEK · Traditional | 10/10/1980SE |
| K802160 | Bun Color Reagent & Bun Acid UsedCDW · Traditional | 10/10/1980SE |
| K802159 | Ammonium Molybdate Inorganic PhosphorusCEO · Traditional | 10/10/1980SE |
| K802158 | Postassium Buffer Sol. & Wash SolutionCEM · Traditional | 10/10/1980SE |
| K802157 | BCG Reagent Serum Albumin W/TechniconCIX · Traditional | 10/10/1980SE |
| K802156 | Reagents Serum Creatine Using TechiconCGX · Traditional | 10/10/1980SE |
Questions and answers
When was Chloride Color & Chloride Sample Diluent cleared by the FDA?
Chloride Color & Chloride Sample Diluent (K802163) received a 510(k) decision of Substantially Equivalent on October 10, 1980, 32 days after the submission was received.
What is the product code of K802163?
The FDA product code is CHJ – Mercuric Thiocyanate, Colorimetry, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.