FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MASTERCAP AM 5.0/MASTERCAP RM 5.0
K Number: K970420
·
Decision Jun 30, 1997
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
129
Review Days
147
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
- MASTERCAP AM 5.0/MASTERCAP RM 5.0
- K Number
- K970420
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pharmacia, Inc.
- Date Received
- February 3, 1997
- Decision Date
- June 30, 1997
- 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
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
MINI SAMPLE PROCESSOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Pharmacia, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974350 | ALLERGAN IMMUNO CAP M4, M8, K70 | Feb 9, 1998 | Substantially Equivalent |
| K972364 | UNICAP PHADIATOP | Sep 4, 1997 | Substantially Equivalent |
| K972068 | UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 | Jul 3, 1997 | Substantially Equivalent |
| K964152 | UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH | Apr 23, 1997 | Substantially Equivalent |
| K962274 | UNICAP 100 | Sep 12, 1996 | Substantially Equivalent |
| K941993 | PHARMACIA CAP SYSTEM PHADIATOP FEIA | Jan 30, 1996 | Substantially Equivalent |
| K954337 | GENOTROPIN MIXER | Nov 13, 1995 | Substantially Equivalent |
| K951025 | PISTON SYRINGE | Oct 19, 1995 | Substantially Equivalent |
| K952025 | ROBOCAP | Jul 26, 1995 | Substantially Equivalent |
| K911903 | ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA | Aug 12, 1991 | Substantially Equivalent |