FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER
K Number: K943493
·
Decision Jan 30, 1995
Classifications
1
FEI Numbers
174
Registration Numbers
174
Same Product Code
207
Applicant Total
16
Review Days
195
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Basic Information
- Device Name
- DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER
- K Number
- K943493
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hamilton Co.
- Date Received
- July 19, 1994
- Decision Date
- January 30, 1995
- Product Code
- JJE
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Hamilton Co.
| K Number | Device Name | ||
|---|---|---|---|
| K961896 | MICROLAB 4000, MICROLAB 4200 | Aug 16, 1996 | 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 |
| K832201 | CHROM-PREP | Aug 16, 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 |