FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WASH SOLUTION KIT, #88102
K Number: K802264
·
Decision Oct 31, 1980
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
52
Review Days
45
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Basic Information
- Device Name
- WASH SOLUTION KIT, #88102
- K Number
- K802264
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hi Chem, Inc.
- Date Received
- September 16, 1980
- Decision Date
- October 31, 1980
- Product Code
- JJF
- 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 |
|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Hi Chem, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960084 | HICHEM GLUCOSE/HK REAGENT KIT | Apr 4, 1996 | Substantially Equivalent |
| K951818 | HICHEM ALT REAGENT KIT | May 15, 1995 | Substantially Equivalent |
| K943684 | HICHEM ENZYME VERIFIER KIT | Oct 4, 1994 | Substantially Equivalent |
| K941764 | HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808 | May 13, 1994 | Substantially Equivalent |
| K902673 | HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND | Jul 17, 1990 | Substantially Equivalent |
| K863617 | ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) | Oct 24, 1986 | Substantially Equivalent |
| K862027 | LDP REAGENT CARTRIDGE (NO. 88216) | Jun 13, 1986 | Substantially Equivalent |
| K861893 | GGT REAGENT CARTRIDGE (PRODUCT NO. 88204) | Jun 5, 1986 | Substantially Equivalent |
| K861879 | CK REAGENT CARTRIDGE (PRODUCT NO. 88213) | May 29, 1986 | Substantially Equivalent |
| K861284 | AP REAGENT CARTRIDGE | Apr 28, 1986 | Substantially Equivalent |