FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FORMICAL
K Number: K821443
·
Decision Jun 2, 1982
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
7
Applicant Total
5
Review Days
19
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Basic Information
- Device Name
- FORMICAL
- K Number
- K821443
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Lerner Laboratories, Inc.
- Date Received
- May 14, 1982
- Decision Date
- June 2, 1982
- Product Code
- KDX
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| KDX | Solution, Decalcifier, Acid Containing | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDX), ordered by most recent decision date.
DECALCIFYING SOLUTION
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SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E
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DECALCIFIER SOLUTION
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DECALCIFIER I
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VOLU-SOL DECALCIFER
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CAL-RITE
FDA 510(k)
FDA Class 1
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Other Clearances by Lerner Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K853694 | XYLENE SUBSTITUTE | Oct 22, 1985 | Substantially Equivalent |
| K854083 | XYLENE SUBSTITUTE MONTANT | Oct 22, 1985 | Substantially Equivalent |
| K761001 | PAP-TRAY II (CATALOG #C600-2) | Dec 6, 1976 | Substantially Equivalent |
| K761000 | PAP-TRAY I (CATALOG #C600-1) | Dec 6, 1976 | Substantially Equivalent |