FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX
K Number: K902541
·
Decision Jun 28, 1990
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
58
Applicant Total
44
Review Days
22
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Basic Information
- Device Name
- MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX
- K Number
- K902541
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Trinity Laboratories, Inc.
- Date Received
- June 6, 1990
- Decision Date
- June 28, 1990
- Product Code
- KTN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | FDA class 2 | Immunology |
Similar 510(k) Clearances
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Other Clearances by Trinity Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981441 | HEART CATH TRAY, STERILE, DISPOSABLE | Jul 10, 1998 | Substantially Equivalent |
| K974238 | DENTAL TRAY, STERILE, DISPOSABLE | Feb 4, 1998 | Substantially Equivalent |
| K974286 | CIRCUMCISION TRAY, CAT. NO. 70340 | Dec 12, 1997 | Substantially Equivalent |
| K972160 | CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST | Aug 1, 1997 | Substantially Equivalent |
| K970722 | EYE TRAY | Mar 31, 1997 | Substantially Equivalent |
| K965201 | O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE | Feb 14, 1997 | Unknown |
| K964921 | BASIC BIOPSY TRAY. DISPOSABLE, STERILE | Jan 22, 1997 | Substantially Equivalent |
| K953929 | MID-STREAM COLLECTION SET-STERILE | Nov 16, 1995 | Substantially Equivalent |
| K952058 | STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE | Sep 21, 1995 | Substantially Equivalent |
| K953070 | WOUNDFOAM 4 X 4 | Sep 8, 1995 | Substantially Equivalent |