FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LASER IMMUNONEPHELOMETRIC ANALYZER
K Number: K772361
·
Decision Jan 30, 1978
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
13
Applicant Total
56
Review Days
34
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Basic Information
- Device Name
- LASER IMMUNONEPHELOMETRIC ANALYZER
- K Number
- K772361
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- G.D. Searle and Co.
- Date Received
- December 27, 1977
- Decision Date
- January 30, 1978
- Product Code
- JQX
- 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 |
|---|---|---|---|
| JQX | Nephelometer, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by G.D. Searle and Co.
| K Number | Device Name | ||
|---|---|---|---|
| K821159 | IN-LINE OXYGEN MONITORING SYSTEM | May 25, 1982 | Substantially Equivalent |
| K811068 | BYPASS COIL | May 27, 1981 | Substantially Equivalent |
| K811071 | VENOUS OXYGEN PROBE | May 5, 1981 | Substantially Equivalent |
| K803238 | INTRAVASCULAR CATHETER | Apr 23, 1981 | Substantially Equivalent |
| K810630 | SILICONE ELASTOMER COATED LATEX FOLEY | Mar 31, 1981 | Substantially Equivalent |
| K810131 | ADMINISTRATION SET | Feb 26, 1981 | Substantially Equivalent |
| K802485 | SEARLE VASCULAR LOOPS | Feb 12, 1981 | Substantially Equivalent |
| K801805 | METRONIDAZOLE DISCS | Feb 10, 1981 | Substantially Equivalent |
| K810112 | SWR DISPOSABLE PREP RAZOR | Feb 4, 1981 | Substantially Equivalent |
| K802213 | WHITE KNIGHT BOVIE CORD/SUCTION TUBE | Oct 10, 1980 | Substantially Equivalent |