FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG
K Number: K844878
·
Decision Feb 25, 1985
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
16
Applicant Total
47
Review Days
70
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Basic Information
- Device Name
- TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG
- K Number
- K844878
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2875
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Hazleton Research Products, Inc.
- Date Received
- December 17, 1984
- Decision Date
- February 25, 1985
- Product Code
- KIP
- Advisory Committee
- Hematology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| KIP | Formulations, Balanced Salt Solutions | FDA class 1 | Hematology |
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DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2
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HEPES BUFFER IM IN NORMAL SALINE
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Other Clearances by Hazleton Research Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861997 | PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE | Jun 10, 1986 | Substantially Equivalent |
| K861996 | DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM | Jun 9, 1986 | Substantially Equivalent |
| K861875 | RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER | May 29, 1986 | Substantially Equivalent |
| K861872 | ISCOVE'S (MODIFIED) DULBECCO'S MEDIUM | May 29, 1986 | Substantially Equivalent |
| K861870 | DULBECCO'S MODIFIED EAGLE MED. W/25MM HEPES BUFFER | May 29, 1986 | Substantially Equivalent |
| K861873 | MEM GLASGOW MEDIUM | May 29, 1986 | Substantially Equivalent |
| K861886 | DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM | May 29, 1986 | Substantially Equivalent |
| K861869 | GENTAMICIN-50MG/ML | May 29, 1986 | Substantially Equivalent |
| K861885 | WILLIAMS MEDIUM E POWDER | May 29, 1986 | Substantially Equivalent |
| K861871 | NCTC 109 MEDIUM | May 29, 1986 | Substantially Equivalent |