The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Magnesium Test Set, Cat. No 0130.
Device ID | K883170 |
510k Number | K883170 |
Device Name: | STANBIO MAGNESIUM TEST SET, CAT. NO 0130 |
Classification | Photometric Method, Magnesium |
Applicant | STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
Contact | William Campbell |
Correspondent | William Campbell STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
Product Code | JGJ |
CFR Regulation Number | 862.1495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-27 |
Decision Date | 1989-02-07 |