FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MULTI-ACCESS REAGENT DISPENSER
K Number: K873416
·
Decision Oct 9, 1987
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
41
Review Days
45
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Basic Information
- Device Name
- MULTI-ACCESS REAGENT DISPENSER
- K Number
- K873416
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Electro-Nucleonics Laboratories, Inc.
- Date Received
- August 25, 1987
- Decision Date
- October 9, 1987
- 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 |
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Other Clearances by Electro-Nucleonics Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873925 | VIRGO(TM) MEASLES IGG ELISA | Feb 24, 1988 | Substantially Equivalent |
| K873617 | GEMSTAR II SYSTEM | Oct 19, 1987 | Substantially Equivalent |
| K873358 | GEMENI URIC ACID U.V. | Sep 11, 1987 | Substantially Equivalent |
| K873088 | VIRGO(TM) RUBELLA IGG ELISA | Sep 9, 1987 | Substantially Equivalent |
| K871905 | TOXOPLASMA GONDII IGG ELISA | Jul 30, 1987 | Substantially Equivalent |
| K870928 | CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS | Apr 22, 1987 | Substantially Equivalent |
| K863874 | LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES | Nov 13, 1986 | Substantially Equivalent |
| K862640 | AMYLASE LTS | Sep 9, 1986 | Substantially Equivalent |
| K853372 | GEMSTAR IPA THEOPHYLLINE TEST KIT | Sep 4, 1985 | Substantially Equivalent |
| K853373 | DELTA TROL I & II | Aug 23, 1985 | Substantially Equivalent |