FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330
K Number: K873329
·
Decision Oct 2, 1987
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
284
Applicant Total
89
Review Days
43
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Basic Information
- Device Name
- HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330
- K Number
- K873329
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Lakewood Biochemical Co., Inc.
- Date Received
- August 20, 1987
- Decision Date
- October 2, 1987
- Product Code
- JSI
- Advisory Committee
- Microbiology
- 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | FDA class 1 | Microbiology |
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Other Clearances by Lakewood Biochemical Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882495 | THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 | Jul 1, 1988 | Substantially Equivalent |
| K882351 | MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 | Jun 28, 1988 | Substantially Equivalent |
| K882463 | POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 | Jun 22, 1988 | Substantially Equivalent |
| K882182 | SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326 | Jun 6, 1988 | Substantially Equivalent |
| K880946 | NUTRIENT GELATIN - PRODUCT NUMBER T2860 | Apr 1, 1988 | Substantially Equivalent |
| K880947 | NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE | Apr 1, 1988 | Substantially Equivalent |
| K880945 | CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597 | Mar 30, 1988 | Substantially Equivalent |
| K875136 | COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750 | Jan 12, 1988 | Substantially Equivalent |
| K874538 | TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516 | Nov 20, 1987 | Substantially Equivalent |
| K874537 | KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR | Nov 20, 1987 | Substantially Equivalent |