Chrom-Prep
FDA 510(k) K832201 · Hamilton Co.
510(k) numberK832201
Submission
- Device name
- Chrom-Prep
- Applicant
- Hamilton Co.
Mchenry, IL, US - Received
- July 7, 1983
- Decision date
- August 16, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KZR – Chromatography (Liquid, Gel), Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2260
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KZR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973074 | 2487 Dual Wavelength Absorbance DetectorKZR · Traditional | Waters Corporation | 10/06/1997SE |
| K931227 | Usdt Flow Immunoassay System, Model 9000KZR · Traditional | U.S. Drug Testing, Inc. | 05/06/1993SE |
| K905538 | Columns Liquid Chromatography DPMKZR · Traditional | Millpore Corp. | 01/25/1991SE |
| K861392 | Syva Solid Phase Columns System IIKZR · Traditional | Syva Co. | 06/13/1986SE |
| K860197 | Series 410 LC PumpKZR · Traditional | The Perkin-Elmer Corp. | 03/17/1986SE |
| K851945 | Varian Aasp Automated Sample Prep. SystemKZR · Traditional | Varian Assoc., Inc. | 05/24/1985SE |
| K843568 | Liquid Chromatograph 400KZR · Traditional | The Perkin-Elmer Corp. | 11/20/1984SE |
| K841890 | Varian 2000 Liquid Chromatography AnalyKZR · Traditional | Varian Assoc., Inc. | 06/14/1984SE |
| K840977 | Liquid Chromatographic Detector LC-95KZR · Traditional | The Perkin-Elmer Corp. | 04/19/1984SE |
| K802725 | Vista 54 Liquid Chromatography Anal. SysKZR · Traditional | Varian Assoc., Inc. | 12/11/1980SE |
More from Varian Assoc., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961896 | Microlab 4000, Microlab 4200JQW · Traditional | 08/16/1996SE |
| K943493 | Discrete Photometric Chemistry AnalyzerJJE · Traditional | 01/30/1995SE |
| K892369 | Multi-Probe Head PlusJTC · Traditional | 06/02/1989SE |
| K873893 | LumiconJJQ · Traditional | 01/05/1988SE |
| K871945 | Microlab atJTC · Traditional | 05/29/1987SE |
| K832205 | Precision Liquid DispenserJQW · Traditional | 08/24/1983SE |
| K832204 | Microlab PJQW · Traditional | 08/24/1983SE |
| K832202 | PB 600 Repeating DispenserJQW · Traditional | 08/24/1983SE |
| K832200 | PRP-1 Reversed Phase Columns for HPLCDPM · Traditional | 08/16/1983SE |
| K832199 | HC40/HC75 Cation Exchange ResinDNH · Traditional | 08/16/1983SE |
Questions and answers
When was Chrom-Prep cleared by the FDA?
Chrom-Prep (K832201) received a 510(k) decision of Substantially Equivalent on August 16, 1983, 40 days after the submission was received.
What is the product code of K832201?
The FDA product code is KZR – Chromatography (Liquid, Gel), Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2260.