FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER
K Number: K905215
·
Decision Jan 11, 1991
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
10
Review Days
52
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Basic Information
- Device Name
- IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER
- K Number
- K905215
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Cirrus Diagnostics, Inc.
- Date Received
- November 20, 1990
- Decision Date
- January 11, 1991
- Product Code
- JJQ
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Cirrus Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K921704 | IMMULITE(R) FSH | Jun 9, 1992 | Substantially Equivalent |
| K920411 | IMMULITE HLH | Mar 11, 1992 | Substantially Equivalent |
| K914833 | IMMULITE DIGOXIN | Nov 22, 1991 | Substantially Equivalent |
| K911796 | IMMULITE(TM) HCG | Jun 20, 1991 | Substantially Equivalent |
| K910677 | IMMULITE(TM) T-UPTAKE | Apr 29, 1991 | Substantially Equivalent |
| K910261 | IMMULITE(TM) TOTAL T4 | Apr 16, 1991 | Substantially Equivalent |
| K905648 | CRP LIPID REAGENT TEST PACK | Mar 6, 1991 | Substantially Equivalent |
| K905214 | IMMULITE (TM) TOTAL T3 | Feb 1, 1991 | Substantially Equivalent |
| K905769 | IMMULITE HS-TSH | Jan 31, 1991 | Substantially Equivalent |