FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NML-5010/5020 MULTI-DETECTOR SYSTEM
K Number: K832002
·
Decision Aug 8, 1983
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
62
Applicant Total
24
Review Days
47
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Basic Information
- Device Name
- NML-5010/5020 MULTI-DETECTOR SYSTEM
- K Number
- K832002
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2320
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Nuclear Medical Laboratories, Inc.
- Date Received
- June 22, 1983
- Decision Date
- August 8, 1983
- Product Code
- JJJ
- 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 |
|---|---|---|---|
| JJJ | Counter (Beta, Gamma) For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Nuclear Medical Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K852438 | NML TSH IRMA | Jul 12, 1985 | Substantially Equivalent |
| K844583 | TSH-STAT | Mar 5, 1985 | Substantially Equivalent |
| K840466 | NML CORTISOL RIA | Mar 30, 1984 | Substantially Equivalent |
| K840589 | TRI-TUBE RIA | Mar 9, 1984 | Substantially Equivalent |
| K832892 | MODIFIED CHORIO-SHURE | Oct 28, 1983 | Substantially Equivalent |
| K823679 | NML 6000 CT | Jan 7, 1983 | Substantially Equivalent |
| K823053 | NML-TETRA-TUBE RIA | Nov 10, 1982 | Substantially Equivalent |
| K822298 | DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI | Sep 2, 1982 | Substantially Equivalent |
| K820523 | CHORIO-QUANT | Mar 15, 1982 | Substantially Equivalent |
| K812759 | NML CK-MB RIA | Oct 19, 1981 | Substantially Equivalent |