FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HICHEM GLUCOSE/HK REAGENT KIT
K Number: K960084
·
Decision Apr 4, 1996
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
144
Applicant Total
52
Review Days
84
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Basic Information
- Device Name
- HICHEM GLUCOSE/HK REAGENT KIT
- K Number
- K960084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hi Chem, Inc.
- Date Received
- January 11, 1996
- Decision Date
- April 4, 1996
- Product Code
- CFR
- 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 |
|---|---|---|---|
| CFR | Hexokinase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Hi Chem, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K861231 | ALT REAGENT CARTRIDGE (PRODUCT NO. 88210) | Apr 28, 1986 | Substantially Equivalent |