Klinar Reagent Pak, #36010
FDA 510(k) K801892 · Hi Chem, Inc.
510(k) numberK801892
Submission
- Device name
- Klinar Reagent Pak, #36010
- Applicant
- Hi Chem, Inc.
Mchenry, IL, US - Received
- August 8, 1980
- Decision date
- October 23, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JGT – Flame Photometry, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K896829 | Technicon Ra Systems Sodium (Colorimetric Method)JGT · Traditional | Technicon Instruments Corp. | 02/23/1990SE |
| K891574 | Lithium Concentrate #SR1031, Na/K Standards SR1030JGT · Traditional | Em Diagnostic Systems, Inc. | 06/09/1989SE |
| K841610 | Components for Potassium, Sodium ChloJGT · Traditional | Shaban Mfg. Co. | 05/25/1984SE |
| K840216 | Sodium/Potassium Reagent SysJGT · Traditional | Sclavo, Inc. | 03/19/1984SE |
| K834248 | Parallel Flame Photometer & SodiumJGT · Traditional | American Monitor Corp. | 01/30/1984SE |
| K811886 | Cesium Diluent 7.5MJGT · Traditional | Gilford Diagnostics | 07/23/1981SE |
| K770774 | Lytetek SystemJGT · Traditional | Boehringer Mannheim Corp. | 07/11/1977SE |
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| K941764 | Hichem Calcium Reagent for the Synchron CX3 Prod. No. 88808CJY · Traditional | 05/13/1994SE |
| K902673 | Hi Chem Total Protein/Albumin Serum Range Lin STNDJJY · Traditional | 07/17/1990SE |
| K863617 | Ion 2/4 Flow Cell Cleaner (Product #88656)JGS · Traditional | 10/24/1986SE |
| K862027 | LDP Reagent Cartridge (No. 88216)CFJ · Traditional | 06/13/1986SE |
| K861893 | GGT Reagent Cartridge (Product No. 88204)JXL · Traditional | 06/05/1986SE |
| K861879 | CK Reagent Cartridge (Product No. 88213)CGS · Traditional | 05/29/1986SE |
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Questions and answers
When was Klinar Reagent Pak, #36010 cleared by the FDA?
Klinar Reagent Pak, #36010 (K801892) received a 510(k) decision of Substantially Equivalent on October 23, 1980, 76 days after the submission was received.
What is the product code of K801892?
The FDA product code is JGT – Flame Photometry, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.