FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHROM-PREP
K Number: K832201
·
Decision Aug 16, 1983
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
14
Applicant Total
16
Review Days
40
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Basic Information
- Device Name
- CHROM-PREP
- K Number
- K832201
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hamilton Co.
- Date Received
- July 7, 1983
- Decision Date
- August 16, 1983
- Product Code
- KZR
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KZR | Chromatography (Liquid, Gel), Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KZR), ordered by most recent decision date.
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Other Clearances by Hamilton Co.
| K Number | Device Name | ||
|---|---|---|---|
| K961896 | MICROLAB 4000, MICROLAB 4200 | Aug 16, 1996 | Substantially Equivalent |
| K943493 | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | Jan 30, 1995 | Substantially Equivalent |
| K892369 | MULTI-PROBE HEAD PLUS | Jun 2, 1989 | Substantially Equivalent |
| K873893 | LUMICON | Jan 5, 1988 | Substantially Equivalent |
| K871945 | MICROLAB AT | May 29, 1987 | Substantially Equivalent |
| K832205 | PRECISION LIQUID DISPENSER | Aug 24, 1983 | Substantially Equivalent |
| K832202 | PB 600 REPEATING DISPENSER | Aug 24, 1983 | Substantially Equivalent |
| K832204 | MICROLAB P | Aug 24, 1983 | Substantially Equivalent |
| K832200 | PRP-1 REVERSED PHASE COLUMNS FOR HPLC | Aug 16, 1983 | Substantially Equivalent |
| K832199 | HC40/HC75 CATION EXCHANGE RESIN | Aug 16, 1983 | Substantially Equivalent |