FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROLAB 4000, MICROLAB 4200
K Number: K961896
·
Decision Aug 16, 1996
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
16
Review Days
92
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MICROLAB 4000, MICROLAB 4200
- K Number
- K961896
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hamilton Co.
- Date Received
- May 16, 1996
- Decision Date
- August 16, 1996
- Product Code
- JQW
- 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 |
|---|---|---|---|
| JQW | Station, Pipetting And Diluting, For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JQW), ordered by most recent decision date.
BD VIPER INSTRUMENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
2700 SAMPLE MANAGER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MASTERCAP AM 5.0/MASTERCAP RM 5.0
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MINI SAMPLER PROCESSOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Hamilton Co.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |