Kleen Test Products Corporation
Strasburg, OH, US
KLEEN TEST PRODUCTS CORPORATION appears in FDA device records in Strasburg, OH. FDA records list 17 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Kleen Test Products Corporation between 1976 and 1989. The busiest year on record is 1985, with 5. The most recent is 1989, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1980 | 4 |
| 1982 | 3 |
| 1984 | 1 |
| 1985 | 5 |
| 1989 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K890039 | KLEEN TEST BASIN SET | JOL | Substantially Equivalent | |
| K890539 | SURE COUNT LIGHT HANDLE COVER | FTA | Substantially Equivalent | |
| K890098 | KLEEN TEST O.R. KIT | LRO | Substantially Equivalent | |
| K853622 | SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030 | Substantially Equivalent | ||
| K853454 | SURE COUNT 5 & 10 SPONGE COUNTER | Substantially Equivalent | ||
| K853315 | CAUTERY TIP CLEANING PAD | Substantially Equivalent | ||
| K852258 | SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER | Substantially Equivalent | ||
| K852257 | SURE-COUNT 15 COUNT NEEDLE COUNTER | Substantially Equivalent | ||
| K844199 | ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET | KKX | Substantially Equivalent | |
| K821396 | OUT-RITE WASTE DISPOSABLE BAG | LDQ | Substantially Equivalent | |
| K821395 | SADDLEBAG INSTRUMENT PAD W/POUCHES | Substantially Equivalent | ||
| K821394 | SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER | MMK | Substantially Equivalent | |
| K801259 | NEEDLE COUNTER-SURE COUNT/100 COUNT | MMK | Substantially Equivalent | |
| K801258 | NEEDLE COUNTER-SURE COUNT/10 COUNT | BXX | Substantially Equivalent | |
| K801257 | NEEDLE COUNTER-SURE COUNT/30 CT. MAGN. | BXX | Substantially Equivalent | |
| K801256 | NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY | BXX | Substantially Equivalent | |
| K760428 | SUTURE RACK & NEEDLE COUNTER | FSM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1526481 | 1526481 | KLEEN TEST PRODUCTS CORPORATION | 216 12TH ST NE, Strasburg, OH 44680 US | 2026 | |
| 3004586080 | 3004586080 | KLEEN TEST PRODUCTS CORPORATION | 1611 S SUNSET RD, Port Washington, WI 53074 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain