510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GLGClass I

Platelet Counting, Manual

21 CFR 864.6160 / Hematology
FDA source (opens on fda.gov)

GLG is the FDA product code for Platelet Counting, Manual, a class I device type, regulated under 21 CFR 864.6160. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GLG
Device name
Platelet Counting, Manual
Regulation
21 CFR 864.6160
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code GLG

By decision year
3 clearances under product code GLG with a decision year between 1977 and 1984, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GLG by decision year
YearClearances
19771
19811
19841

Applicants with the most clearances

Product code GLG
Applicants holding the most 510(k) clearances under product code GLG
ApplicantClearances
E K Ind., Inc.1
Labtronix Corp.1
Streck Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code