FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
J.T. BAKER LSA 290 PIPETTER/DILUTER
K Number: K801090
·
Decision Jun 9, 1980
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
139
Applicant Total
54
Review Days
32
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Basic Information
- Device Name
- J.T. BAKER LSA 290 PIPETTER/DILUTER
- K Number
- K801090
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2750
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- J.T. Baker Chemical Co.
- Date Received
- May 8, 1980
- Decision Date
- June 9, 1980
- 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 J.T. Baker Chemical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K803128 | SERIES 810 PLATELET ANALYZER | Apr 3, 1981 | Substantially Equivalent |
| K802080 | BAKER DIAG. ULTRARATE CHLORIDE KIT | Oct 10, 1980 | Substantially Equivalent |
| K802035 | BAKER DIAG. ULTRARATE CO2 REAGENT KIT | Sep 26, 1980 | Substantially Equivalent |
| K801909 | LSA 290 ASSAY REAGENTS/NEPHELOMETRIC | Sep 26, 1980 | Substantially Equivalent |
| K801662 | J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. | Sep 16, 1980 | Substantially Equivalent |
| K801669 | J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO | Sep 16, 1980 | Substantially Equivalent |
| K801661 | J.T. BAKER CERULOPLASMIN NEPHELOMETRIC | Sep 16, 1980 | Substantially Equivalent |
| K801795 | BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. | Sep 16, 1980 | Substantially Equivalent |
| K801362 | ALBUMIN NEPHELOMETRIC ASSAY | Jul 21, 1980 | Substantially Equivalent |
| K801432 | HEMOPEXIN NEPHELOMETRIC ASSAY | Jul 8, 1980 | Substantially Equivalent |