PRP-1 Reversed Phase Resin
FDA 510(k) K832197 · Hamilton Co.
510(k) numberK832197
Submission
- Device name
- PRP-1 Reversed Phase Resin
- Applicant
- Hamilton Co.
Walker, MI, US - Received
- July 7, 1983
- Decision date
- August 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DMZ – Liquid Chromatography, Adsorbent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2260
- Specialty
- Clinical Chemistry
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|---|---|---|
| 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 |
| K832201 | Chrom-PrepKZR · Traditional | 08/16/1983SE |
| K832200 | PRP-1 Reversed Phase Columns for HPLCDPM · Traditional | 08/16/1983SE |
Questions and answers
When was PRP-1 Reversed Phase Resin cleared by the FDA?
PRP-1 Reversed Phase Resin (K832197) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 36 days after the submission was received.
What is the product code of K832197?
The FDA product code is DMZ – Liquid Chromatography, Adsorbent, a Class I (low risk) device regulated under 21 CFR 862.2260.